The Value of Oral Micronized Progesterone in the Prevention of Spontaneous

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT02571296
Study type	Interventional
Source	Ghamra Military Hospital
Contact	ahmed A Abdel-Aziz
Phone	00201006215841
Email	ahmedallam402@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	July 2015
Completion date	June 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms