Completed

NCT Number: NCT00646802

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

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.

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Key information

Conditions

Threatened Premature Labor

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Son Llàtzer, Palma de Mallorca, Balearic Islands, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone

Drug

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

Placebo

Drug

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

Primary outcomes

Proportion of deliveries before week 34 of gestation

Time frame: week 34 of gestation

Secondary outcomes

Median time from randomization to delivery

Time frame: delivery
Ultrasound cervical length

Time frame: week +5

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial

Acronym: PROMISE

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Mar 31, 2008
Registry last updated: Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.