Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/18/2018 |
| Start Date: | February 2010 |
| End Date: | October 2018 |
Preterm birth is the leading cause of neonatal death and a significant cause of life long
disability and health problems. It has been shown that the drug 17-hydroxyprogesterone
caproate can help reduce the risk of preterm delivery in women with certain risk factors for
preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy
in a group of patients in whom this medication has not been previously studied. Specifically,
we hope to learn whether progesterone supplementation will delay delivery in women with
pre-term, premature rupture of membranes (PPROM).
disability and health problems. It has been shown that the drug 17-hydroxyprogesterone
caproate can help reduce the risk of preterm delivery in women with certain risk factors for
preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy
in a group of patients in whom this medication has not been previously studied. Specifically,
we hope to learn whether progesterone supplementation will delay delivery in women with
pre-term, premature rupture of membranes (PPROM).
When women present to either the Obstetrical clinic or labor and delivery with a complaint of
possible preterm, premature rupture of membranes (PPROM), they will be examined by an
obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM,
they will then be admitted to Lucile Packard Children's Hospital and treated with the normal
protocol which includes receiving antibiotics, receiving steroids, being hospitalized until
delivery, and having ongoing maternal and fetal monitoring for possible complications. The
patients will be identified by their treating obstetricians as possible study candidates and
asked by a member of the treatment team if they are potentially interested in participating
in a research study. Subsequently, a member of the study team or the treating physician will
approach the patient about participating in the trial. Those who choose to participate will
receive the standard care protocol in addition to receiving the study medication. The study
medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or
placebo. The placebo medication (castor oil) was chosen as it has been used in previous
studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the
patient receives will be determined by a randomization table. Only the pharmacist will be
aware of the medication that has been administered. The patient, members of the treatment
team, and members of the study team will be blinded to the medication that is being
administered. The timing of their delivery will be managed by the treating obstetrician
according to standard medical practice. After delivery, the patient's and her infant's
medical outcomes will be recorded for analysis.
possible preterm, premature rupture of membranes (PPROM), they will be examined by an
obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM,
they will then be admitted to Lucile Packard Children's Hospital and treated with the normal
protocol which includes receiving antibiotics, receiving steroids, being hospitalized until
delivery, and having ongoing maternal and fetal monitoring for possible complications. The
patients will be identified by their treating obstetricians as possible study candidates and
asked by a member of the treatment team if they are potentially interested in participating
in a research study. Subsequently, a member of the study team or the treating physician will
approach the patient about participating in the trial. Those who choose to participate will
receive the standard care protocol in addition to receiving the study medication. The study
medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or
placebo. The placebo medication (castor oil) was chosen as it has been used in previous
studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the
patient receives will be determined by a randomization table. Only the pharmacist will be
aware of the medication that has been administered. The patient, members of the treatment
team, and members of the study team will be blinded to the medication that is being
administered. The timing of their delivery will be managed by the treating obstetrician
according to standard medical practice. After delivery, the patient's and her infant's
medical outcomes will be recorded for analysis.
Inclusion Criteria:
1. 18yr of age
2. Singleton pregnancy
3. PPROM confirmed on clinical exam
4. GA between 24+0 and 33+5 wk
5. Ability to understand consent in either English or Spanish
Exclusion Criteria:
1. Contraindication to ongoing pregnancy including:
1. Evidence of active infection
2. Evidence of significant placental abruption
3. IUFD diagnosed at the time of P-PROM diagnosis
2. Major fetal malformation
3. Maternal allergy to progesterone or placebo drug components
4. Current use of progesterone at the time of P-PROM
5. Multiple Gestations
6. Inability to understand consent in either English or Spanish
We found this trial at
2
sites
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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