Cervical Length, Preterm Delivery
Conditions
Keywords
nulliparous, pregnancy, short cervix, progesterone
Brief summary
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.
Detailed description
Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?
Interventions
DRUG17 alpha-hydroxyprogesterone caproate
Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OTHERPlacebo Oil
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients and care providers are masked to treatment assignment.
Intervention model description
Treatment with 17 alpha-hydroxyprogesterone caproate via weekly injections of 250 mg of 17p until 37 weeks gestation or delivery vs. weekly injections of placebo oil until 37 weeks gestation or delivery.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous * Cervical length as measured on transvaginal examination \< 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days * Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization
Exclusion criteria
* Multifetal gestation * Progesterone treatment after 14 weeks 6 days during current pregnancy * Vaginal bleeding, heavier than spotting, after 15 weeks 6 days * Amniotic membranes prolapsed beyond external os * Preterm rupture of membranes * Fetal anomaly * Pregnancy without a viable fetus * Current or planned cervical cerclage * Congenital Mullerian abnormality of the uterus * Contraindication to intra-muscular injections * Hypertension requiring medication * Diabetes managed with insulin or oral hypoglycemic agents * DES exposure * Cervical surgery such as cold knife conization * Planned indicated preterm delivery * Participation in another interventional study that influences age at delivery * Participation in this trial in a previous pregnancy * Prenatal care or delivery planned outside a MFMU Network center
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Delivering Before 37 Weeks Gestation | Delivery before 37 weeks gestation | Number of participants delivering before 37 weeks gestation by indication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Gestational Age at Delivery | Delivery | Mean gestational age at delivery |
| Number of Participants With Preterm Premature Rupture of Membranes | <37 weeks | — |
| Number of Participants Who Delivered Before 35 Weeks Gestation | Delivery | Delivery before 35 weeks gestation |
| Number of Participants Who Delivered Before 32 Weeks Gestation | Delivery | Delivery before 32 weeks gestation |
| Number of Participants Who Delivered Before 28 Weeks Gestation | Delivery | Delivery before 28 weeks gestation |
| Number of Participants Who Visited the Hospital Due to Preterm Labor | Between randomization and 37 weeks gestation | Number of participants who visited the hospital due to preterm labor before 37 weeks gestation |
| Number of Participants Who Underwent Tocolytic Therapy | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | Number of participants who underwent tocolytic therapy during pregnancy |
| Number of Participants Who Underwent Corticosteroid Therapy | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | Number of participants who underwent corticosteroid therapy in pregnancy |
| Number of Participants Who Had a Cerclage Placement | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | Number of participants who had a cerclage placement |
| Number of Participants With Gestational Diabetes Mellitus | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | — |
| Number of Participants Experiencing Cholestasis | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | — |
| Number of Participants Who Experienced Placental Abruption | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | — |
| Number of Participants Experiencing Gestational Hypertension or Preeclampsia | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | — |
| Number of Participants Who Had Cesarean Delivery | delivery | — |
| Number of Participants Who Reported Side Effects | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site |
| Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | within 72 hours of delivery | comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis |
| Mean Birth Weight | Delivery | Birth weight as measured in grams |
| Birth Weight by Count of Participants | Delivery | Birth weight by count of participants \< 2500 grams and \< 1500 grams |
| Number of Neonates Who Measured Small for Gestational Age | Delivery | Birth weight percentile and small for gestational age \<10th percentile based on number of weeks and gender. |
| Number of Participants With Apgar Score of Less Than 7 at 5 Minutes | 5 minutes post delivery | The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. |
| Number of Neonates With a Major Congenital Anomaly | Delivery | Presence of a major congenital anomaly at birth |
| Number of Neonates With Patent Ductus Arteriosus | Delivery through neonatal discharge | Number of neonates diagnosed with the heart defect patent ductus arteriosus |
| Number of Neonates Experiencing Seizures | Delivery through neonatal discharge | Number of neonates experiencing seizures from delivery to hospital discharge |
| Number of Neonates Admitted to NICU | Delivery through hospital discharge | Admission to the neonatal intensive care unit |
| Median Length of NICU Stay | NICU admission through NICU discharge | Median length of stay in the neonatal intensive care unit in days |
| Number of Participants Who Experienced Chorioamnionitis | Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks | — |
Countries
United States
Participant flow
Recruitment details
From April 2007 through May 2011, the fourteen centers of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development participated in this randomized double-blind placebo-controlled trial. Eligible women were offered participation.
Pre-assignment details
Women who signed informed consent received a compliance injection of the placebo and were asked to return at least 3 days later for randomization. If a woman did not return for a randomization visit before 23 weeks 0 days of gestation, she was excluded.
Participants by arm
| Arm | Count |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate 17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first. | 327 |
| Placebo castor oil | 330 |
| Total | 657 |
Baseline characteristics
| Characteristic | Total | 17 Alpha-hydroxyprogesterone Caproate | Placebo |
|---|---|---|---|
| Age, Continuous | 22.2 years STANDARD_DEVIATION 4.9 | 22.8 years STANDARD_DEVIATION 5.3 | 21.6 years STANDARD_DEVIATION 4.4 |
| Alcohol use during pregnancy | 53 Participants | 33 Participants | 20 Participants |
| Cervical funnel length | 15.6 mm STANDARD_DEVIATION 8.4 | 14.8 mm STANDARD_DEVIATION 8 | 16.7 mm STANDARD_DEVIATION 8.7 |
| Cervical funnel present | 157 Participants | 88 Participants | 69 Participants |
| Cervical length at screening | 23.8 mm STANDARD_DEVIATION 5.7 | 23.9 mm STANDARD_DEVIATION 5.6 | 23.8 mm STANDARD_DEVIATION 5.7 |
| Cervical length at screening <15mm | 56 Participants | 25 Participants | 31 Participants |
| Debris present | 78 Participants | 39 Participants | 39 Participants |
| Gestational age at randomization | 21.4 weeks STANDARD_DEVIATION 1.3 | 21.4 weeks STANDARD_DEVIATION 1.2 | 21.3 weeks STANDARD_DEVIATION 1.3 |
| Illicit substance use during pregnancy | 39 Participants | 15 Participants | 24 Participants |
| Married or living with partner | 235 Participants | 125 Participants | 110 Participants |
| Payment for obstetric care Government-assisted insurance | 474 Participants | 236 Participants | 238 Participants |
| Payment for obstetric care Private insurance | 136 Participants | 74 Participants | 62 Participants |
| Payment for obstetric care Uninsured/self-pay | 47 Participants | 17 Participants | 30 Participants |
| Prepregnancy body mass index | 25.7 kg^m2 STANDARD_DEVIATION 6.7 | 26.1 kg^m2 STANDARD_DEVIATION 6.9 | 25.4 kg^m2 STANDARD_DEVIATION 6.5 |
| Prior Pregnancy 13-19 wk of gestation | 23 Participants | 13 Participants | 10 Participants |
| Prior Pregnancy <13 wk of gestation | 174 Participants | 92 Participants | 82 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic black | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic white | 57 Participants | 19 Participants | 38 Participants |
| Race/Ethnicity, Customized Non-hispanic black | 340 Participants | 179 Participants | 161 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 150 Participants | 76 Participants | 74 Participants |
| Race/Ethnicity, Customized Other | 101 Participants | 47 Participants | 54 Participants |
| Sex: Female, Male Female | 657 Participants | 327 Participants | 330 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking during pregnancy | 110 Participants | 48 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 326 / 326 | 328 / 328 |
| serious Total, serious adverse events | 22 / 327 | 13 / 330 |
Outcome results
Primary
Number of Participants Delivering Before 37 Weeks Gestation
Number of participants delivering before 37 weeks gestation by indication
Time frame: Delivery before 37 weeks gestation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Delivering Before 37 Weeks Gestation | Total Delivery <37 wk | 82 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Delivering Before 37 Weeks Gestation | Spontaneous | 54 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Delivering Before 37 Weeks Gestation | Medically indicated | 27 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Delivering Before 37 Weeks Gestation | Fetal loss/abortion <20 wk | 1 Participants |
| Placebo | Number of Participants Delivering Before 37 Weeks Gestation | Fetal loss/abortion <20 wk | 0 Participants |
| Placebo | Number of Participants Delivering Before 37 Weeks Gestation | Total Delivery <37 wk | 80 Participants |
| Placebo | Number of Participants Delivering Before 37 Weeks Gestation | Medically indicated | 25 Participants |
| Placebo | Number of Participants Delivering Before 37 Weeks Gestation | Spontaneous | 55 Participants |
Comparison: All deliveries less than 37 weeks95% CI: [0.79, 1.35]
Comparison: Spontaneous deliveries95% CI: [0.7, 1.4]
Comparison: Medically-indicated deliveries95% CI: [0.65, 1.84]
Secondary
Birth Weight by Count of Participants
Birth weight by count of participants \< 2500 grams and \< 1500 grams
Time frame: Delivery
Population: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Birth Weight by Count of Participants | Birth weight < 2500g | 72 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Birth Weight by Count of Participants | Birth weight < 1500g | 23 Participants |
| Placebo | Birth Weight by Count of Participants | Birth weight < 2500g | 75 Participants |
| Placebo | Birth Weight by Count of Participants | Birth weight < 1500g | 29 Participants |
Secondary
Mean Birth Weight
Birth weight as measured in grams
Time frame: Delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Mean Birth Weight | 2855 Grams | Standard Deviation 747 |
| Placebo | Mean Birth Weight | 2824 Grams | Standard Deviation 807 |
p-value: 0.82Wilcoxon (Mann-Whitney)
Secondary
Mean Gestational Age at Delivery
Mean gestational age at delivery
Time frame: Delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Mean Gestational Age at Delivery | 37.6 weeks | Standard Deviation 3.9 |
| Placebo | Mean Gestational Age at Delivery | 37.4 weeks | Standard Deviation 4.3 |
p-value: 0.93Wilcoxon (Mann-Whitney)
Secondary
Median Length of NICU Stay
Median length of stay in the neonatal intensive care unit in days
Time frame: NICU admission through NICU discharge
Population: Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Median Length of NICU Stay | 17 days |
| Placebo | Median Length of NICU Stay | 15.5 days |
p-value: 0.61Wilcoxon (Mann-Whitney)
Secondary
Number of Neonates Admitted to NICU
Admission to the neonatal intensive care unit
Time frame: Delivery through hospital discharge
Population: Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates Admitted to NICU | 63 Participants |
| Placebo | Number of Neonates Admitted to NICU | 69 Participants |
Secondary
Number of Neonates Experiencing Seizures
Number of neonates experiencing seizures from delivery to hospital discharge
Time frame: Delivery through neonatal discharge
Population: Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates Experiencing Seizures | 1 Participants |
| Placebo | Number of Neonates Experiencing Seizures | 2 Participants |
Secondary
Number of Neonates Who Measured Small for Gestational Age
Birth weight percentile and small for gestational age \<10th percentile based on number of weeks and gender.
Time frame: Delivery
Population: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates Who Measured Small for Gestational Age | < 3rd percentile | 15 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates Who Measured Small for Gestational Age | < 10th percentile | 54 Participants |
| Placebo | Number of Neonates Who Measured Small for Gestational Age | < 10th percentile | 47 Participants |
| Placebo | Number of Neonates Who Measured Small for Gestational Age | < 3rd percentile | 14 Participants |
Secondary
Number of Neonates With a Major Congenital Anomaly
Presence of a major congenital anomaly at birth
Time frame: Delivery
Population: Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates With a Major Congenital Anomaly | 6 Participants |
| Placebo | Number of Neonates With a Major Congenital Anomaly | 2 Participants |
Secondary
Number of Neonates With Patent Ductus Arteriosus
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Time frame: Delivery through neonatal discharge
Population: Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Neonates With Patent Ductus Arteriosus | 2 Participants |
| Placebo | Number of Neonates With Patent Ductus Arteriosus | 8 Participants |
Secondary
Number of Participants Experiencing Cholestasis
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 1 participant in the Placebo group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Experiencing Cholestasis | 1 Participants |
| Placebo | Number of Participants Experiencing Cholestasis | 0 Participants |
Secondary
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 1 participant in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Experiencing Gestational Hypertension or Preeclampsia | 46 Participants |
| Placebo | Number of Participants Experiencing Gestational Hypertension or Preeclampsia | 40 Participants |
95% CI: [0.78, 1.72]
Secondary
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis
Time frame: within 72 hours of delivery
Population: With the exception of the composite outcome and death, the neonatal outcomes were only measured for live births.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Composite Outcome Total | 23 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Fetal Death | 4 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Neonatal Death | 6 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Respiratory Distress Syndrome | 13 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Bronchopulmonary dysplasia | 3 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Necrotizing enterocolitis, grade II or III | 2 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Intraventricular Hemorrhage, Grade III or IV | 2 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Periventricular Leukomalacia | 4 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Early-onset Sepsis | 3 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Retinopathy of prematurity, grade II or IV | 1 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Periventricular Leukomalacia | 1 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Composite Outcome Total | 30 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Necrotizing enterocolitis, grade II or III | 5 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Fetal Death | 1 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Retinopathy of prematurity, grade II or IV | 3 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Neonatal Death | 8 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Intraventricular Hemorrhage, Grade III or IV | 1 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Respiratory Distress Syndrome | 16 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Early-onset Sepsis | 11 Participants |
| Placebo | Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components | Bronchopulmonary dysplasia | 5 Participants |
Comparison: Analysis is for the total composite95% CI: [0.46, 1.3]
Secondary
Number of Participants Who Delivered Before 28 Weeks Gestation
Delivery before 28 weeks gestation
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Delivered Before 28 Weeks Gestation | 15 Participants |
| Placebo | Number of Participants Who Delivered Before 28 Weeks Gestation | 22 Participants |
95% CI: [0.36, 1.3]
Secondary
Number of Participants Who Delivered Before 32 Weeks Gestation
Delivery before 32 weeks gestation
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Delivered Before 32 Weeks Gestation | 28 Participants |
| Placebo | Number of Participants Who Delivered Before 32 Weeks Gestation | 32 Participants |
95% CI: [0.54, 1.43]
Secondary
Number of Participants Who Delivered Before 35 Weeks Gestation
Delivery before 35 weeks gestation
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Delivered Before 35 Weeks Gestation | 44 Participants |
| Placebo | Number of Participants Who Delivered Before 35 Weeks Gestation | 53 Participants |
95% CI: [0.58, 1.21]
Secondary
Number of Participants Who Experienced Chorioamnionitis
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 2 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Experienced Chorioamnionitis | 29 Participants |
| Placebo | Number of Participants Who Experienced Chorioamnionitis | 20 Participants |
95% CI: [0.84, 2.52]
Secondary
Number of Participants Who Experienced Placental Abruption
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 2 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Experienced Placental Abruption | 11 Participants |
| Placebo | Number of Participants Who Experienced Placental Abruption | 15 Participants |
95% CI: [0.34, 1.58]
Secondary
Number of Participants Who Had a Cerclage Placement
Number of participants who had a cerclage placement
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Had a Cerclage Placement | 6 Participants |
| Placebo | Number of Participants Who Had a Cerclage Placement | 4 Participants |
95% CI: [0.43, 5.33]
Secondary
Number of Participants Who Had Cesarean Delivery
Time frame: delivery
Population: Data was missing for 1 participant in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Had Cesarean Delivery | 67 Participants |
| Placebo | Number of Participants Who Had Cesarean Delivery | 63 Participants |
95% CI: [0.79, 1.46]
Secondary
Number of Participants Who Reported Side Effects
Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Reported Side Effects | Any | 223 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Reported Side Effects | Injection site | 217 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Reported Side Effects | Urticaria | 10 Participants |
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Reported Side Effects | Nausea | 7 Participants |
| Placebo | Number of Participants Who Reported Side Effects | Nausea | 10 Participants |
| Placebo | Number of Participants Who Reported Side Effects | Any | 220 Participants |
| Placebo | Number of Participants Who Reported Side Effects | Urticaria | 2 Participants |
| Placebo | Number of Participants Who Reported Side Effects | Injection site | 209 Participants |
Comparison: Any side effect95% CI: [0.92, 1.13]
Comparison: Injection site95% CI: [0.93, 1.17]
Comparison: Urticaria95% CI: [1.11, 22.78]
Comparison: Nausea95% CI: [0.27, 1.83]
Secondary
Number of Participants Who Underwent Corticosteroid Therapy
Number of participants who underwent corticosteroid therapy in pregnancy
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Underwent Corticosteroid Therapy | 55 Participants |
| Placebo | Number of Participants Who Underwent Corticosteroid Therapy | 51 Participants |
95% CI: [0.77, 1.55]
Secondary
Number of Participants Who Underwent Tocolytic Therapy
Number of participants who underwent tocolytic therapy during pregnancy
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Population: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Underwent Tocolytic Therapy | 35 Participants |
| Placebo | Number of Participants Who Underwent Tocolytic Therapy | 42 Participants |
95% CI: [0.55, 1.29]
Secondary
Number of Participants Who Visited the Hospital Due to Preterm Labor
Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Time frame: Between randomization and 37 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants Who Visited the Hospital Due to Preterm Labor | 145 Participants |
| Placebo | Number of Participants Who Visited the Hospital Due to Preterm Labor | 151 Participants |
95% CI: [0.82, 1.15]
Secondary
Number of Participants With Apgar Score of Less Than 7 at 5 Minutes
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.
Time frame: 5 minutes post delivery
Population: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants With Apgar Score of Less Than 7 at 5 Minutes | 15 Participants |
| Placebo | Number of Participants With Apgar Score of Less Than 7 at 5 Minutes | 19 Participants |
Secondary
Number of Participants With Gestational Diabetes Mellitus
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants With Gestational Diabetes Mellitus | 15 Participants |
| Placebo | Number of Participants With Gestational Diabetes Mellitus | 13 Participants |
95% CI: [0.56, 2.41]
Secondary
Number of Participants With Preterm Premature Rupture of Membranes
Time frame: <37 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | Number of Participants With Preterm Premature Rupture of Membranes | 25 Participants |
| Placebo | Number of Participants With Preterm Premature Rupture of Membranes | 24 Participants |
95% CI: [0.61, 1.8]