Pregnancy Complications
Conditions
Brief summary
Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.
Detailed description
The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study. In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.
Interventions
DRUGProgesterone
Progesterone 400 mg per vagina qhs.
DRUGPolyethylene glycol&hydrogenated vegetable oil.
Placebo Comparator: Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina qhs.
Sponsors
Stanford University
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 55 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant. 2\. Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5. Cervical dilation less than or equal to 4cm
Exclusion criteria
1. Any contraindication to on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5. Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known allergy to any component of the study medication or placebo 9. Severe maternal medical illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Delivery Rate Prior to 37 Weeks Gestation | Up to 37 weeks of gestation | Reduction in delivery rate prior to 37 weeks gestation (preterm birth). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birthweight | At the time of newborn birth | Newborn birthweight in grams |
| Neonatal Intensive Care Unit (NICU) Admission | At time of neonatal discharge | — |
| Neonatal Morbidity | Up to 28 days after neonatal birth | — |
| Maternal Anticipated Adverse Medication Reaction | Up to the maternal discharge from delivery hospitalization | — |
| Neonatal Congenital Abnormalities | Up to the time of neonatal discharge from the delivery hospital | — |
| Number of Days Delay of Delivery | Up to the time of delivery | Number of days from intervention to delivery |
| Maternal Chorioamnionitis | Up to maternal hospital discharge | — |
| Neonatal Mortality | Up to 28 days after neonatal birth | — |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled from November 2010 through February 2011.
Participants by arm
| Arm | Count |
|---|---|
| Progesterone Progesterone 400 mg per vagina qhs. | 4 |
| Polyethylene Glycol & Hydrogenated Vegetable Oil Polyethylene glycol 400 distearate & hydrogenated vegetable oil | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Progesterone | Polyethylene Glycol & Hydrogenated Vegetable Oil | Total |
|---|---|---|---|
| Age, Continuous | 28.5 years | 27.0 years | 27.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 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 | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Reduction in Delivery Rate Prior to 37 Weeks Gestation
Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
Time frame: Up to 37 weeks of gestation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Progesterone | Reduction in Delivery Rate Prior to 37 Weeks Gestation | Delivery at <37 weeks of gestation | 2 Participants |
| Progesterone | Reduction in Delivery Rate Prior to 37 Weeks Gestation | Delivery at >=37 weeks of gestation | 2 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Reduction in Delivery Rate Prior to 37 Weeks Gestation | Delivery at <37 weeks of gestation | 0 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Reduction in Delivery Rate Prior to 37 Weeks Gestation | Delivery at >=37 weeks of gestation | 2 Participants |
Secondary
Birthweight
Newborn birthweight in grams
Time frame: At the time of newborn birth
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Progesterone | Birthweight | 2740 grams |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Birthweight | 3275 grams |
Secondary
Maternal Anticipated Adverse Medication Reaction
Time frame: Up to the maternal discharge from delivery hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone | Maternal Anticipated Adverse Medication Reaction | 1 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Maternal Anticipated Adverse Medication Reaction | 0 Participants |
Secondary
Maternal Chorioamnionitis
Time frame: Up to maternal hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone | Maternal Chorioamnionitis | 0 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Maternal Chorioamnionitis | 0 Participants |
Secondary
Neonatal Congenital Abnormalities
Time frame: Up to the time of neonatal discharge from the delivery hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progesterone | Neonatal Congenital Abnormalities | 0 Neonates |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Neonatal Congenital Abnormalities | 0 Neonates |
Secondary
Neonatal Intensive Care Unit (NICU) Admission
Time frame: At time of neonatal discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone | Neonatal Intensive Care Unit (NICU) Admission | 2 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Neonatal Intensive Care Unit (NICU) Admission | 0 Participants |
Secondary
Neonatal Morbidity
Time frame: Up to 28 days after neonatal birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone | Neonatal Morbidity | 1 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Neonatal Morbidity | 0 Participants |
Secondary
Neonatal Mortality
Time frame: Up to 28 days after neonatal birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone | Neonatal Mortality | 0 Participants |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Neonatal Mortality | 0 Participants |
Secondary
Number of Days Delay of Delivery
Number of days from intervention to delivery
Time frame: Up to the time of delivery
Population: exact delivery data unavailable for one term participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Progesterone | Number of Days Delay of Delivery | 38.0 days |
| Polyethylene Glycol&Hydrogenated Vegetable Oil | Number of Days Delay of Delivery | 47.5 days |