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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01206998
Other study ID # VagPro 27515
Secondary ID
Status Withdrawn
Phase N/A
First received September 20, 2010
Last updated September 28, 2012
Start date July 2010
Est. completion date August 2010

Study information

Verified date September 2012
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.


Description:

Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or older

- Singleton gestation

- Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate

- Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.

- Management with standard of care tocolytic therapy (nifedipine)

- Planned delivery at Strong Memorial Hospital or Highland Hospital

Exclusion Criteria:

- Cervical dilation more than 4 cm.

- Evidence of rupture of membranes

- Negative fetal fibronectin (if done prior to admission)

- Cervical length greater than 3 cm

- Presence of cervical cerclage

- Major fetal anomaly

- Small for gestational age, i.e., fetuses with estimated fetal weight below the 10th percentile by ultrasound

- Evidence of chorioamnionitis (Temperature >100.4oF with uterine tenderness and maternal or fetal tachycardia or purulent discharge)

- Suspected placental abruption or significant hemorrhage

- Category III fetal heart rate pattern

- Presence of co-existing medical conditions, including maternal diabetes and hypertension and seizure disorder

- Use of any progesterone in current pregnancy within 4 weeks of enrollment

- First dose of standard tocolytic therapy more than 6 hours prior to randomization

- Allergies to progesterone and progesterone gel

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vaginal progesterone gel
Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)
Placebo vaginal gel
Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug

Locations

Country Name City State
United States Strong Memorial Hospital Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Juniper Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Latency to delivery Time in days from randomization day to day of end of pregnancy No
Secondary Cervical length within 24 hours of first tocolytic dose and at first week follow up No
Secondary Delivery prior to 37, 34 and 32 weeks after delivery No
Secondary Number of subsequent hospital admissions for preterm labor after delivery No
See also
  Status Clinical Trial Phase
Completed NCT03171480 - Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia Phase 4
Completed NCT00397735 - N-acetylcysteine in Intra-amniotic Infection/Inflammation Phase 1/Phase 2
Completed NCT00209326 - A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor Phase 2
Terminated NCT03682822 - Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial N/A
Terminated NCT00137501 - Two Dose Regimens of Nifedipine for the Management of Preterm Labor Phase 3
Terminated NCT00641784 - Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population Phase 3
Completed NCT00599898 - Nifedipine Compared to Atosiban for Treating Preterm Labor Phase 4
Completed NCT00059683 - Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women N/A
Completed NCT00432250 - The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor. Phase 4
Terminated NCT00116623 - Magnesium Sulfate Versus Indomethacin for Preterm Labor Phase 4
Not yet recruiting NCT04105881 - Correlation Between Vitamin D and B Regulatory Cell in Pregnancy