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The Use of Progesterone to Reduce Preterm Birth
This study is ongoing, but not recruiting participants.
First Received: December 16, 2008   Last Updated: January 27, 2009   History of Changes
Sponsored by: University of Mississippi Medical Center
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00830765
  Purpose

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.


Condition Intervention
Preterm Birth
Drug: Progesterone (OHP17)
Drug: Placebo

Drug Information available for: Progesterone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: The Use of Progesterone to Reduce Preterm Birth

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • The aim is to compare progesterone to a placebo to ascertain if there is a reduction in preterm birth among patients receiving the active drug. [ Time Frame: after delivery of infant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The aim of this study is to compare progesterone with a placebo to ascertain if there is a reduction in neonatal morbidity among patients receiving the active drug. [ Time Frame: after delivery of the infant ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: June 2004
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Failure to meet inclusion criteria as noted above; contraindication to pregnancy continuation; severe medical diseases such as sickle cell disease with crises, diabetes mellitus (F/R/H), severe preeclampsia etc., (physician judgment; severe fetal/obstetric criteria such as intrauterine growth restriction (<5th percentile, placental abruption,placental previa, etc., (physician judgment); non reassuring fetal assessment; allergy to progesterone compounds; refusal to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830765

Locations
United States, Mississippi
Winfred L Wiser Hospital for Women and Infants at the University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: John C Morrison, MD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: University of Mississippi Medical Center ( John C Morrison, MD )
Study ID Numbers: 2003-0239
Study First Received: December 16, 2008
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00830765     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Pregnancy Complications
Progesterone
Hormone Antagonists
Progestins
Obstetric Labor, Premature
Hormones, Hormone Substitutes, and Hormone Antagonists
Obstetric Labor Complications
Hormones
Premature Birth

Additional relevant MeSH terms:
Pregnancy Complications
Progesterone
Progestins
Obstetric Labor, Premature
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Obstetric Labor Complications
Hormones
Pharmacologic Actions
Premature Birth

ClinicalTrials.gov processed this record on May 06, 2009