Maurice L. Druzin
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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 suffcient 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.
Recruiting Status:
Not yet recruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Drug: Progesterone
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to 55 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant.
2. Intact membranes
3. Singleton pregnancy
4. Greater than or equal to 18 years of age
5. Cervical dilation less than or equal to 4cm
Key Exclusion Criteria:
1. Any contraindication to on-going pregnancy
2. Placental abruption
3. Placenta previa
4. Lethal fetal anomalies
5. Premature rupture of membranes
6. Multiple gestation
7. Less than 18 years old
8. Known allergy to any component of the study medication or placebo
9. Severe maternal medical illness
Additional Study Details
Official Title:
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled TrialAnticipated start date:
10/1/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Reduction in delivery rate prior to 37 weeks gestation
Secondary Outcomes:
- Neonatal: Birth weight, NICU admission and length of stay
- Neonatal morbidity and mortality
- Neonatal congenital abnormalities, specifically genital abnormalities
- Maternal chorioamnionitis, adverse medication reaction, patient report of labor symptoms and number of days of delay of delivery.
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
120More Information
Secondary ID(s):
- 11625
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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