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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00646802
Other study ID # PROMISE
Secondary ID
Status Completed
Phase Phase 4
First received March 26, 2008
Last updated August 18, 2016
Start date June 2008
Est. completion date May 2012

Study information

Verified date August 2016
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 (ß-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

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


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
Placebo
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Locations

Country Name City State
Spain Hospital Clinic de Barcelona Barcelona
Spain Institut Universitari Dexeus Barcelona
Spain Hospital de Basurto Bilbao
Spain Hospital Puerta del Mar Cádiz
Spain Complejo Hospitalario Universitario Insular-Materno Infantil Las Palmas de Gran Canaria Gran Canaria
Spain Hospital U Gregorio Marañon Madrid
Spain Hospital Sant joan de Déu de Manresa Manresa Barcelona
Spain Hospital Son Llàtzer Palma de Mallorca Islas Baleares
Spain Corporació Sanitària Parc Taulí Sabadell Barcelona
Spain Hospital Virgen de la Macarena Seville
Spain Hospital de Terrassa. CST Terrassa Barcelona
Spain Hospital Clinico U. Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of deliveries before week 34 of gestation week 34 of gestation No
Secondary Median time from randomization to delivery delivery No
Secondary Ultrasound cervical length week +5 No