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

NCT00646802 | Completed Phase 4 DMC

• 1 other identifier: PROMISE
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 12

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.

Conditions

Threatened Premature Labor

Outcome Measures

Primary Outcomes (1)

• Proportion of deliveries before week 34 of gestation

  week 34 of gestation

Secondary Outcomes (2)

• Median time from randomization to delivery

  delivery

• Ultrasound cervical length

  week +5

Study Arms (2)

A

ACTIVE COMPARATOR

Progesterone 200 mg

Drug: Progesterone

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Progesterone DRUG

1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days

A

Placebo DRUG

1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (12)

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Institut Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Sant joan de Déu de Manresa

Manresa, Barcelona, 08243, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Terrassa. CST

Terrassa, Barcelona, 08227, Spain

Location

Hospital de Basurto

Bilbao, Bilbao, 48013, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

Location

Hospital U Gregorio Marañon

Madrid, Madrid, 28009, Spain

Location

Hospital Virgen de la Macarena

Seville, Seville, 41009, Spain

Location

Hospital Clinico U. Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Montse Palacio, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

ES (12)