The Value of Oral Micronized Progesterone in the Prevention of Spontaneous Preterm Birth

Preterm Birth Clinical Trial

Official title:

The Value of Oral Micronized Progesterone in the Prevention of Spontaneous Preterm Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02571296
• Other study ID #: 310
• Status: Recruiting
• Phase: Phase 4
• First received: October 1, 2015
• Last updated: October 7, 2015
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Ghamra Military Hospital
• Contact: ahmed A Abdel-Aziz
• Phone: 00201006215841
• Email: ahmedallam402[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study.

Description:

Intervention:

The study subjects will be randomized to receive twice daily tablets of either 100 mg of OMP (Uterocare®, October Pharma , Sixth of October city, Egypt) or placebo from enrollment (14-18 weeks) until 36 weeks or delivery, whichever occurs first. The patients and medical staff will be blinded to the study medication allocation.

Method of Randomization:

All patients who are fit for admission into the study will pull one of the numbered sealed identical black bags containing either the active medicine (=25%), the placebo (with the aim of admission into data collection, =25%), or a placebo together with a short note explaining that they will not be admitted to the study (=50%) and that they can give back their bag to the head nurse.

The code for the 424 (106x4) bag numbers is a confidential computer generated random number list (generated using MedCalc© Software bvba, Ostend, Belgium). It will be left, in a sealed envelope, with the head nurse of the antenatal clinic, till the end of data collection.ruptured membranes.

5. Obstetric ultrasound for gestational age, amniotic fluid volume, fetal weight, placental position, fetal anomalies.

6. Transvaginal ultrasound is not always available for cervical length assessment in ASUMH, so it will not be a necessary step in patients assessment but will be done whenever available.

Follow up:

Patients will be followed up regularly, at twice monthly intervals, in the antenatal clinic of Ain Shams University Maternity Hospital until delivery. They will be instructed to return to the hospital when recurrence of symptoms of preterm labor, rupture of membranes, or vaginal bleeding. There will be telephone call follow ups routinely to ensure adherence to the study protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Singleton pregnancies.

2. Gestational age, on admission, is between 14 and 18 weeks.

3. Past history of at least one idiopathic preterm birth.

Exclusion Criteria:

1. Established preterm labor (cervical dilatation = 4 cm).

2. Persistent uterine contractions.

3. Women with medical or surgical complications indicating delivery or termination of pregnancy.

4. Presence of fetal anomalies incompatible with life.

5. Premature rupture of membranes.

Study Design

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• micronized progesterone
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Egypt	Ahmed Adel Abdel-Aziz	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ghamra Military Hospital	Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate (incidence) of preterm delivery (gestational age <37 weeks).	Patients will be followed up regularly, at twice monthly intervals, in the antenatal clinic of Ain Shams University Maternity Hospital until delivery. They will be instructed to return to the hospital when recurrence of symptoms of preterm labor, rupture of membranes, or vaginal bleeding. There will be telephone call follow up routinely to ensure adherence to the study protocol.	up to 37weeks.	Yes
Secondary	The incidence of rupture of the amniotic membranes.	Patients will be followed up regularly, at twice monthly intervals, in the antenatal clinic of Ain Shams University Maternity Hospital until delivery. They will be instructed to return to the hospital when recurrence of symptoms of preterm labor, rupture of membranes, or vaginal bleeding. There will be telephone call follow up routinely to ensure adherence to the study protocol.	up to 37weeks.	Yes
Secondary	The neonatal birth weight	Patients will be followed up regularly, at twice monthly intervals, in the antenatal clinic of Ain Shams University Maternity Hospital until delivery.	up to 37 weeks.	Yes