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Completed

NCT Number: NCT01050647

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

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).

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Santa Clara Valley Medical Center, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18yr of age
  • Singleton pregnancy
  • PPROM confirmed on clinical exam
  • GA between 24+0 and 33+5 wk
  • Ability to understand consent in either English or Spanish

Exclusion criteria

  • Contraindication to ongoing pregnancy including:
  • Evidence of active infection
  • Evidence of significant placental abruption
  • IUFD diagnosed at the time of P-PROM diagnosis
  • Major fetal malformation
  • Maternal allergy to progesterone or placebo drug components
  • Current use of progesterone at the time of P-PROM
  • Multiple Gestations
  • Inability to understand consent in either English or Spanish

Treatment and study plan

17-hydroxyprogesterone caproate

Drug

Weekly injections of 17-hydroxyprogesterone caproate.

Other names: Active study drug

Caster Oil injections

Other

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Other names: Placebo

Primary outcomes

  1. Number of Participants With Achievement of 34 Weeks Gestation

    Time frame: From enrollment until delivery, an average of 34 weeks

    Delayed delivery until 34 weeks gestation.

Secondary outcomes

  1. Number of Participants With Neonatal Respiratory Distress Syndrome

    Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months

  2. Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage

    Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months

  3. Number of Participants With Neonatal Necrotizing Enterocolitis

    Time frame: From delivery to neonatal discharge, assessed up to 2 months

  4. Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days

    Time frame: From birth to discharge form delivery hospital, assessed up to 2 months

  5. Length of Latency Assessed as Number of Days

    Time frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2010
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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