Preterm Birth
Conditions
Keywords
Preterm Birth, Preterm Delivery, Multiple gestation, 17-alpha-hydroxyprogesterone caproate, Progesterone
Brief summary
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: 1. Twin pregnancy 2. Triplet pregnancy
Detailed description
Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity. In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates. The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth.
Interventions
DRUG17-alpha-hydroxyprogesterone caproate injectable
250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.
DRUGPlacebo
Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
Sponsors
Obstetrix Medical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Gestational age (GA) 15-23w0d gestational age at the time of recruitment 2. GA 16w0dk to 23w6d at the time of randomization and initiation of injections 3. Maternal age 18 years or older 4. One of these risk factors for spontaneous preterm birth: 1. Twins in current pregnancy, dichorionic placentation 2. Triplets in current pregnancy, trichorionic placentation 5. Intact membranes 6. Patient has had at least one detailed 2nd-trimester ultrasound examination documenting placentation, chorionicity, fetal number, fetal size, amniotic fluid volumes, and fetal anatomy. (This examination must comply with minimum standards such as those published by the American Institute of Ultrasound in Medicine, American College of Radiology, or American College of Obstetricians & Gynecologists It is NOT mandatory that this examination be performed at the research-study center.) 7. Investigator believes patient will be reliable with follow-up visits and believes that delivery data and neonatal data are likely to be available.
Exclusion criteria
1. Symptomatic uterine contractions in current pregnancy 2. Contraindication to interventions intended to prolong the pregnancy (including lethal fetal anomalies, amnionitis, preeclampsia, severe oligohydramnios, severe growth delay, fetal death appears imminent or inevitable) 3. Risk factors for major neonatal morbidity unrelated to preterm delivery (such as monochorionic placentation in multiple gestation, major malformations, certain medication exposures) 4. Preexisting maternal medical condition that might be worsened by progesterone therapy, including: asthma requiring medications, renal insufficiency, seizure disorder, ischemic heart disease, active cholecystitis, impaired liver function, history of thromboembolic disorder, history of breast cancer, history of major depression requiring hospitalization. 5. Preexisting maternal medical condition associated with a high risk of preterm delivery including: refractory hypertension, diabetes with nephropathy or retinopathy, renal insufficiency, active systemic lupus erythematosus. Note that a history of prior preterm birth is NOT an exclusion. 6. Use of progesterone or progesterone-derivative medication after 15 weeks gestation in current pregnancy. 7. Allergy to 17OHP or oil vehicle. 8. Placement of emergent cerclage (defined as one placed after the occurrence of cervical change such as dilation, funneling, or effacement) with this pregnancy. Prophylactic cerclage is NOT an exclusion (defined as one placed before any cervical change, for example, because of a history of cervical incompetence, or because of a prior cervical procedure such as LEEP or cone biopsy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perinatal Death | measured from randomization to 28 days after birth. | Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization. |
| Newborn Sepsis | measured during the first week following birth | Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics. |
| Newborn Pneumonia | measure during the first 28 days after birth. | Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia |
| Newborn Intraventricular Hemorrhage Grade 3 or 4 | measured during the first 28 days after birth | Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension. |
| Newborn Periventricular Leukomalacia (PVL) | measured in the first 28 days after birth. | Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter. |
| Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery | measured in the first 28 days after birth | Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis. |
| Newborn Retinopathy of Prematurity (ROP) | measured during the first 28 day after birth | Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy. |
| Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver | measured during the first 28 days after delivery | Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis). |
| Newborn Respiratory Distress Syndrome (RDS) | Measured from delivery until 30 days after baby was discharged from the hospital | Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes. |
| Use of Oxygen Therapy at 28 Days of Newborn Life | Measured at 28 days after birth. | Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Gestational age noted at time of birth | Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks) |
| Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | noted at delivery | Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks) |
| Newborn Gestational Age (GA) at Delivery | determined at the time of birth | Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth. |
| Newborn Birthweight | measure following delivery | Newborn Birthweight within the twins group was measure following delivery and noted in grams. |
| Participant Drop-out Rates | any time from randomization to completion of final dose of study medication | Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy). |
| Participant Side Effects Requiring Cessation of Therapy | anytime from initial injection to final injection at 34 weeks. | Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy. |
| Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death) | measured as any event noted in the first 28 day following birth. | Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death). |
Countries
United States
Participant flow
Recruitment details
Potential women carrying a twin or triplet pregnancy meeting defined inclusion and exclusion criteria were recruited from participating outpatient medical clinics from November, 2004 to August 2009.
Pre-assignment details
During the pre-assignment period, subjects were consented to participate, giving a compliance injection of Castor Oil and brought back 5 to 9 days later for re-evaluation. Exclusions were made based on the presence of a reaction to the injection, not meeting inclusion/exclusion criteria or the participates desire not to participate.
Participants by arm
| Arm | Count |
|---|---|
| 1 Test Group (170HP) Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. | 216 |
| 2 - Control (Castor Oil) Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. | 105 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | 1 Test Group (170HP) | 2 - Control (Castor Oil) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 216 Participants | 105 Participants | 321 Participants |
| Age, Continuous triplets | 33.4 years STANDARD_DEVIATION 5 | 33.6 years STANDARD_DEVIATION 5.4 | 33.5 years STANDARD_DEVIATION 5.2 |
| Age, Continuous twins | 34.0 years STANDARD_DEVIATION 5.8 | 34.5 years STANDARD_DEVIATION 6.6 | 34.3 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 216 participants | 105 participants | 321 participants |
| Sex: Female, Male Female | 216 Participants | 105 Participants | 321 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 216 | 18 / 105 |
| serious Total, serious adverse events | 69 / 216 | 34 / 105 |
Outcome results
Primary
Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver
Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).
Time frame: measured during the first 28 days after delivery
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver | 0 Twins |
| Twins Group - Placebo Arm | Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver | 0 Twins |
Primary
Newborn Intraventricular Hemorrhage Grade 3 or 4
Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension.
Time frame: measured during the first 28 days after birth
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Intraventricular Hemorrhage Grade 3 or 4 | 3 Twins |
| Twins Group - Placebo Arm | Newborn Intraventricular Hemorrhage Grade 3 or 4 | 0 Twins |
Primary
Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery
Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.
Time frame: measured in the first 28 days after birth
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery | 0 Twins |
| Twins Group - Placebo Arm | Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery | 0 Twins |
Primary
Newborn Periventricular Leukomalacia (PVL)
Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.
Time frame: measured in the first 28 days after birth.
Population: The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Periventricular Leukomalacia (PVL) | 1 participants |
| Twins Group - Placebo Arm | Newborn Periventricular Leukomalacia (PVL) | 1 participants |
Primary
Newborn Pneumonia
Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia
Time frame: measure during the first 28 days after birth.
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Pneumonia | 1 Twins |
| Twins Group - Placebo Arm | Newborn Pneumonia | 0 Twins |
Primary
Newborn Respiratory Distress Syndrome (RDS)
Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes.
Time frame: Measured from delivery until 30 days after baby was discharged from the hospital
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Respiratory Distress Syndrome (RDS) | 44 Twins |
| Twins Group - Placebo Arm | Newborn Respiratory Distress Syndrome (RDS) | 18 Twins |
Primary
Newborn Retinopathy of Prematurity (ROP)
Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.
Time frame: measured during the first 28 day after birth
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Retinopathy of Prematurity (ROP) | 2 Twins |
| Twins Group - Placebo Arm | Newborn Retinopathy of Prematurity (ROP) | 0 Twins |
Primary
Newborn Sepsis
Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.
Time frame: measured during the first week following birth
Population: The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Sepsis | 3 participants |
| Twins Group - Placebo Arm | Newborn Sepsis | 1 participants |
Primary
Perinatal Death
Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.
Time frame: measured from randomization to 28 days after birth.
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Perinatal Death | 0 Twins |
| Twins Group - Placebo Arm | Perinatal Death | 3 Twins |
Primary
Use of Oxygen Therapy at 28 Days of Newborn Life
Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.
Time frame: Measured at 28 days after birth.
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Use of Oxygen Therapy at 28 Days of Newborn Life | 9 Twins |
| Twins Group - Placebo Arm | Use of Oxygen Therapy at 28 Days of Newborn Life | 0 Twins |
Secondary
Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)
Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).
Time frame: measured as any event noted in the first 28 day following birth.
Population: Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death) | 46 Twins - Components of Neonatal Morbidity |
| Twins Group - Placebo Arm | Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death) | 19 Twins - Components of Neonatal Morbidity |
Secondary
Newborn Birthweight
Newborn Birthweight within the twins group was measure following delivery and noted in grams.
Time frame: measure following delivery
Population: Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Birthweight | 2321 grams | Standard Deviation 523 |
| Twins Group - Placebo Arm | Newborn Birthweight | 2469 grams | Standard Deviation 543 |
Secondary
Newborn Gestational Age (GA) at Delivery
Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.
Time frame: determined at the time of birth
Population: Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twins Group = Test Arm - 17OHP | Newborn Gestational Age (GA) at Delivery | 35.3 weeks of age for twin pregnancy | Standard Deviation 2.5 |
| Twins Group - Placebo Arm | Newborn Gestational Age (GA) at Delivery | 35.9 weeks of age for twin pregnancy | Standard Deviation 2.3 |
Secondary
Participant Drop-out Rates
Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).
Time frame: any time from randomization to completion of final dose of study medication
Population: Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Participant Drop-out Rates | 8 participants |
| Twins Group - Placebo Arm | Participant Drop-out Rates | 5 participants |
Secondary
Participant Side Effects Requiring Cessation of Therapy
Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.
Time frame: anytime from initial injection to final injection at 34 weeks.
Population: Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twins Group = Test Arm - 17OHP | Participant Side Effects Requiring Cessation of Therapy | 6 participants |
| Twins Group - Placebo Arm | Participant Side Effects Requiring Cessation of Therapy | 0 participants |
Secondary
Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks
Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)
Time frame: noted at delivery
Population: Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twins Group = Test Arm - 17OHP | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 28 weeks of gestation | 9 Triplet Pregnancies |
| Twins Group = Test Arm - 17OHP | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 32 weeks of gestation | 19 Triplet Pregnancies |
| Twins Group = Test Arm - 17OHP | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 35 weeks of gestation | 43 Triplet Pregnancies |
| Twins Group - Placebo Arm | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 28 weeks of gestation | 2 Triplet Pregnancies |
| Twins Group - Placebo Arm | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 32 weeks of gestation | 13 Triplet Pregnancies |
| Twins Group - Placebo Arm | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Delivery before 35 weeks of gestation | 13 Triplet Pregnancies |
Secondary
Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks
Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)
Time frame: Gestational age noted at time of birth
Population: Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twins Group = Test Arm - 17OHP | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 28 weeks of gestation | 3 Twin Pregnancies |
| Twins Group = Test Arm - 17OHP | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 32 weeks of gestation | 15 Twin Pregnancies |
| Twins Group = Test Arm - 17OHP | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 34 weeks of gestation | 31 Twin Pregnancies |
| Twins Group = Test Arm - 17OHP | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 37 weeks of gestation | 113 Twin Pregnancies |
| Twins Group - Placebo Arm | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 37 weeks of gestation | 46 Twin Pregnancies |
| Twins Group - Placebo Arm | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 28 weeks of gestation | 1 Twin Pregnancies |
| Twins Group - Placebo Arm | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 34 weeks of gestation | 11 Twin Pregnancies |
| Twins Group - Placebo Arm | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Delivery before 32 weeks of gestation | 4 Twin Pregnancies |