Progesterone for the Management of Preterm, Premature Rupture of

Status Completed

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01050647
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	February 2010
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03249896` - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes	N/A
Completed	`NCT06338254` - Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women	N/A
Recruiting	`NCT04825093` - Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19	N/A
Completed	`NCT04739462` - SMS Maama Project COVID-19	N/A
Recruiting	`NCT04519593` - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	N/A
Recruiting	`NCT03313024` - Berlin-Brandenburg Pregnancy Cohort
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06357962` - Semi-permanent Acupuncture Effect on Cervical Ripening	N/A
Not yet recruiting	`NCT06430853` - Psychobiological Interventions in Pregnancy	N/A
Not yet recruiting	`NCT03661749` - Urinary Protein to Creatinine Ratio in Term Pregnant Women	N/A
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Completed	`NCT02191774` - Medical Abortion up to 10 Weeks Gestation at Home
Completed	`NCT01322529` - Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be	N/A
Completed	`NCT00678080` - Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes	N/A
Completed	`NCT00746551` - Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment	Phase 4
Completed	`NCT00634530` - Impact of a Nutritional Intervention Program for Weight Control During Pregnancy	N/A
Completed	`NCT00197561` - Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection	Phase 3
Completed	`NCT05527327` - Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study	N/A
Recruiting	`NCT05551078` - Thrombophilia Screening After Severe IUGR
Recruiting	`NCT03100084` - PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms