NCT01840228

Brief Summary

Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 18, 2019

Completed
Last Updated

June 18, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

April 17, 2013

Results QC Date

May 7, 2019

Last Update Submit

May 29, 2019

Conditions

Premature BirthObstetric Labor, Premature

Keywords

PretermProgesterone

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Delivered Before 37 Weeks'

    Duration of current pregnancy, anticipated maximum 18 weeks

Secondary Outcomes (7)

  • Number of Participants Who Delivered Before 34 Weeks'

    Duration of current pregnancy, anticipated maximum 18 weeks

  • Delivery Within 2 Weeks of Randomization

    2 weeks

  • Number of Weeks Pregnancy Prolongation

    Duration of current pregnancy, anticipated maximum 18 weeks

  • Infant Birth Weight

    Day of delivery in current pregnancy

  • Neonatal Intensive Care Unit Admission

    Followed for duration of neonatal hospital stay, estimated maximum 16 weeks

  • +2 more secondary outcomes

Study Arms (2)

Micronized progesterone suppository

ACTIVE COMPARATOR

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Drug: Micronized progesterone suppository

Placebo suppository

PLACEBO COMPARATOR

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Drug: Micronized progesterone suppository

Interventions

Micronized progesterone suppositoryDRUG
Micronized progesterone suppositoryPlacebo suppository

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton or twin gestation
  • Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
  • Initially present with regular contractions and clinical diagnosis of preterm labor but remain undelivered with 1) no further cervical change 12 hours after discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge based on attending physician judgment prior to the 12 hour period of time
  • The participant's cervix must be at least 1 cm at the time of enrollment

You may not qualify if:

  • Non-English speaking
  • Rupture of membranes
  • Chorioamnionitis
  • Non-reassuring fetal status
  • Maternal indication for delivery
  • Placental abruption
  • Intrauterine fetal demise
  • Prenatally diagnosed major fetal anomaly
  • Cervical cerclage in place
  • Previous administration of progesterone during the current pregnancy for a history of preterm birth or short cervix
  • Participant is either unwilling or unable to attend follow-up study visits following hospital discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine/ Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

  • Lyell DJ, Pullen KM, Mannan J, Chitkara U, Druzin ML, Caughey AB, El-Sayed YY. Maintenance nifedipine tocolysis compared with placebo: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1221-1226. doi: 10.1097/AOG.0b013e31818d8386.

    PMID: 19037029BACKGROUND

  • Likis FE, Edwards DR, Andrews JC, Woodworth AL, Jerome RN, Fonnesbeck CJ, McKoy JN, Hartmann KE. Progestogens for preterm birth prevention: a systematic review and meta-analysis. Obstet Gynecol. 2012 Oct;120(4):897-907. doi: 10.1097/AOG.0b013e3182699a15.

    PMID: 22955308BACKGROUND

  • Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.

    PMID: 21472815BACKGROUND

  • Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.

    PMID: 17671254BACKGROUND

  • Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2008 Feb;48(1):58-63. doi: 10.1111/j.1479-828X.2007.00803.x.

    PMID: 18275573BACKGROUND

  • Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73. doi: 10.1159/000328719. Epub 2011 Nov 12.

    PMID: 22086108BACKGROUND

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Dr. Heather Frey
Organization
Ohio State University
Heather.Frey@osumc.edu
614-688-6798

Study Officials

  • George A Macones, MD, MSCE

    Washington University School of Medicine

    STUDY CHAIR

  • Heather A Frey, MD, MSCI

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

June 18, 2019

Results First Posted

June 18, 2019

Record last verified: 2019-05

Locations

US(1)