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Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

2014-08-27 03:16:34 | BioPortfolio

Summary

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).

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pregnancy Complications

Intervention

17-Hydroxyprogesterone Caproate

Location

Stanford University School of Medicine
Stanford
California
United States
94305

Status

Recruiting

Source

Stanford University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

Clinical Trials [851 Associated Clinical Trials listed on BioPortfolio]

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontan...

A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix

We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to ...

Treatment of Preterm Labor With 17 Alpha-Hydroxyprogesterone Caproate

The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emergin...

17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies

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 mo...

Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery

As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical...

PubMed Articles [2532 Associated PubMed Articles listed on BioPortfolio]

Response to 17-alpha hydroxyprogesterone caproate.

Defining the Clinical Response to 17-alpha hydroxyprogesterone Caproate.

Erratum to: A Double-Blind, Randomized, Placebo-Controlled Trial of 17 Alpha-hydroxyprogesterone Caproate in the Management of Preterm Premature Rupture of Membranes.

PROLONG Clinical Study Protocol: Hydroxyprogesterone Caproate to Reduce Recurrent Preterm Birth.

The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, ...

17OHP-C in patients with spontaneous preterm labor and intact membranes: is there an effect according to the presence of intra-amniotic inflammation?

It is not known whether 17-alpha-hydroxyprogesterone caproate (17OHP-C) is effective for preventing preterm delivery with an episode of preterm labor (PTL) with or without intra-amniotic inflammation/...

Medical and Biotech [MESH] Definitions

Round-shaped structure usually located in the upper fundus of the UTERUS in early pregnancy. It comprises EMBRYO; AMNIOTIC FLUID; and YOLK SAC. It is visible in PRENATAL ULTRASONOGRAPHY by the fifth week of pregnancy. Its size is often used to determine and monitor GESTATIONAL AGE; FETAL GROWTH; and PREGNANCY COMPLICATIONS.

Conditions or pathological processes associated with pregnancy. They can occur during or after pregnancy, and range from minor discomforts to serious diseases that require medical interventions. They include diseases in pregnant females, and pregnancies in females with diseases.

The co-occurrence of pregnancy and NEOPLASMS. The neoplastic disease may precede or follow FERTILIZATION.

The co-occurrence of pregnancy and an INFECTION. The infection may precede or follow FERTILIZATION.

The co-occurrence of pregnancy and parasitic diseases. The parasitic infection may precede or follow FERTILIZATION.

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