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N/A N=144 Randomized Quadruple-blind Treatment

The Use of Progesterone to Reduce Preterm Birth

Preterm Birth

Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Weeks Gestation at Birth Among Patients Receiving the Active Drug. — 31.9; 30.2 weeks

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Progesterone (OHP17) (Drug); Placebo (Drug)
Age
Pediatric, Adult · 16+ yrs
Sex
Female
Sponsor
University of Mississippi Medical Center
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Weeks Gestation at Birth Among Patients Receiving the Active Drug.
31.9; 30.2

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00830765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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