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

NCT02571296 | Unknown Phase 4

• 1 other identifier: 310
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth

Keywords

Preterm Birth; Oral Micronized Progesterone

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• The incidence of rupture of the amniotic membranes.

  up to 37weeks.

• The neonatal birth weight

  up to 37 weeks.

Study Arms (2)

group A

ACTIVE COMPARATOR

subjects will recieve twice daily tablets of 100 mg of oral Micronized Progesterone from (14-18 weeks) until 36 weeks or delivery. Subjects: 106 cases Name: Oral micron ized progesterone Form: oral tablets Dosage: one tablet Frequency: every 12 hours Duration: 14-36 weeks gestational age.

Drug: micronized progesterone

Group B

PLACEBO COMPARATOR

subjects will receive placebo twice daily from (14-18 weeks) until 36 weeks or delivery. Subjects: 106 cases Name: placebo Form: oral tablets Dosage: one tablet Frequency: every 12 hours Duration: 14-36 weeks gestational age.

Drug: Placebo

Interventions

micronized progesterone DRUG

Oral

Also known as: Uterocare

group A

Placebo DRUG

Oral

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancies.
• Gestational age, on admission, is between 14 and 18 weeks.
• Past history of at least one idiopathic preterm birth.

You may not qualify if:

• Established preterm labor (cervical dilatation ≥ 4 cm).
• Persistent uterine contractions.
• Women with medical or surgical complications indicating delivery or termination of pregnancy.
• Presence of fetal anomalies incompatible with life.
• Premature rupture of membranes.

Sponsors & Collaborators

• Ghamra Military Hospital: lead
• Ain Shams Maternity Hospital: collaborator

Study Sites (1)

Ahmed Adel Abdel-Aziz

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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

• Ahmed Abdel-Aziz

  Ain Shams Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed A Abdel-Aziz

CONTACT

00201006215841; ahmedallam402@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar of OB/GYN

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 8, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

EG (1)