Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

NCT00946088 | Terminated Phase 2 Results

• 2 other identifiers: SU-03312009-207811625
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Reduction in Delivery Rate Prior to 37 Weeks Gestation

  Reduction in delivery rate prior to 37 weeks gestation (preterm birth).

  Up to 37 weeks of gestation

Secondary Outcomes (8)

• Maternal Chorioamnionitis

  Up to maternal hospital discharge

• Maternal Anticipated Adverse Medication Reaction

  Up to the maternal discharge from delivery hospitalization

• Birthweight

  At the time of newborn birth

• Neonatal Intensive Care Unit (NICU) Admission

  At time of neonatal discharge

• Neonatal Morbidity

  Up to 28 days after neonatal birth

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

Progesterone 400mg per vagina qhs.

Drug: Progesterone

Polyethylene glycol&hydrogenated vegetable oil

PLACEBO COMPARATOR

Polyethylene glycol\&hydrogenated vegetable oil per vagina

Drug: Polyethylene glycol&hydrogenated vegetable oil.

Interventions

Progesterone DRUG

Progesterone 400 mg per vagina qhs.

Progesterone

Polyethylene glycol&hydrogenated vegetable oil. DRUG

Placebo Comparator: Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina qhs.

Polyethylene glycol&hydrogenated vegetable oil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

Very limited enrollment, study terminated early.

Results Point of Contact

• Title: Deirdre Lyell, MD
• Organization: Stanford University School of Medicine

deirdre.lyell@stanford.edu

(650) 384-5107

Study Officials

• Deirdre Judith Lyell, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2015
• Last Updated: March 16, 2017
• Results First Posted: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)