The Use of Progesterone to Reduce Preterm Birth

NCT00830765 | Completed Results

• 1 other identifier: 2003-0239
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for another early delivery). There are other studies that show that this technique of giving a weekly shot of progesterone does not prevent preterm birth. In addition, There are other groups of patients who are at very high risk for preterm birth which have not been studied. They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal gestation (twins, triplets, etc.); 3.) Women with preterm (\<34 weeks) rupture of the membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes who have been tocolyzed (have their labor stopped and are getting ready to go home). We purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in the first group who are at risk for preterm delivery due to an early birth in a previous pregnancy as well as the other four groups listed. If progesterone given weekly is successful at preventing early delivery as compared to the placebo group then great benefit for these women as well as future pregnancies would be accrued.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Weeks Gestation at Birth Among Patients Receiving the Active Drug.

  Weeks gestation at birth, the interval to delivery, or neonatal morbitity.

  Through delivery, until discharge up to 40 weeks gestation

Study Arms (2)

1 Placebo

PLACEBO COMPARATOR

The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.

Drug: Placebo

Progesterone

ACTIVE COMPARATOR

The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.

Drug: Progesterone (OHP17)

Interventions

Progesterone (OHP17) DRUG

100mg of OHP17 or comparable amount of placebo administered by IM injection weekly until either 34 weeks' gestation or delivery has been achieved, whichever occurs first.

Progesterone

Placebo DRUG

2cc of placebo liquid formulated by pharmacy personnel at the University of Mississippi Medical Center injected IM weekly until 34 weeks' gestation has been reached or delivery, whichever occurs first.

1 Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnancy 20 - 34 weeks; cervical dilation \<4 cm; risk for preterm birth; multifetal gestation; diagnosis of preterm labor during the current pregnancy effectively tocolyzed); preterm rupture of the fetal membranes (24 - 34 weeks); willing and able to sign Informed Consent Form

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Winfred L Wiser Hospital for Women and Infants at the University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (2)

• Briery CM, Klauser CK, Martin RW, Magann EF, Chauhan SP, Morrison JC. The use of 17-hydroxy progesterone in women with arrested preterm labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2014 Dec;27(18):1892-6. doi: 10.3109/14767058.2014.892922. Epub 2014 Mar 10.

  PMID: 24512252 DERIVED

• Briery CM, Veillon EW, Klauser CK, Martin RW, Magann EF, Chauhan SP, Morrison JC. Women with preterm premature rupture of the membranes do not benefit from weekly progesterone. Am J Obstet Gynecol. 2011 Jan;204(1):54.e1-5. doi: 10.1016/j.ajog.2010.08.022.

  PMID: 20869038 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; 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

Results Point of Contact

• Title: Dr John Morrison
• Organization: UMississippi

jmorrison@umc.edu

601-984-5300

Study Officials

• John C Morrison, MD

  University of Mississippi Medical Center

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ob-Gyn

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: January 28, 2009
• Study Start: June 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 20, 2013
• Results First Posted: February 20, 2013

Record last verified: 2013-01

Locations

US (1)