Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

Phase 4

Completed

• Conditions: Threatened Premature Labor
• Interventions: Drug: Progesterone; Drug: Placebo

• Registration Number: NCT00646802
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-31
• Study Start: 2008-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

Inclusion Criteria

• Pregnant women aged between 18 - 45 years
• Gestational age between 24.0 and before 33.6 gestational weeks
• Singleton pregnancy
• Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
• Ultrasound cervical length at discharge < 25 mm
• Signed patient consent form (CI)

Exclusion Criteria

• Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
• Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
• With known allergy to progesterone or peanuts (excipient).
• Grade 2 (or upper) renal or liver laboratory abnormalities
• Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
• With Diabetes mellitus or insulinized gestational diabetes
• Treated with heparin
• Drug abuse
• Inadequate treatment compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Progesterone	Progesterone 200 mg
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Proportion of deliveries before week 34 of gestation	week 34 of gestation

Secondary Outcome Measures

Name	Time	Method
Ultrasound cervical length	week +5
Median time from randomization to delivery	delivery

Trial Locations

Locations (12)

Hospital Sant joan de Déu de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Hospital Virgen de la Macarena; 🇪🇸 Seville, Spain

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Complejo Hospitalario Universitario Insular-Materno Infantil; 🇪🇸 Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital de Terrassa. CST; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital U Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital Clinico U. Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain