Different Types of Progesterone in the Prevention of Preterm Labor

NCT03537287 | Unknown Phase 2 DMC

• 1 other identifier: PDPTL
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life.. There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• Gestational age in weeks at delivery.

  using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery

  6 months

Secondary Outcomes (7)

• Hemodynamic changes in fetoplacental circulation

  6 months

• Unsatisfactory response

  6 months

• Failure of prevention of preterm labor

  6 months

• Birth weight

  6 months

• Neonatal APGAR score

  6 months

Study Arms (3)

17 alpha hydroxyprogestrone caproate Group

ACTIVE COMPARATOR

Patients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks.

Drug: 17 alpha hydroxyprogestrone caproate

Vaginal progesterone Group

ACTIVE COMPARATOR

Patients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks.

Drug: Vaginal progesterone

Oral dydrogesterone Group

ACTIVE COMPARATOR

Patients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks

Drug: Oral dydrogesterone

Interventions

17 alpha hydroxyprogestrone caproate DRUG

250 mg of 17 alpha hydroxyprogestrone caproate weekly

17 alpha hydroxyprogestrone caproate Group

Vaginal progesterone DRUG

200 mg of vaginal progesterone daily

Vaginal progesterone Group

Oral dydrogesterone DRUG

2 tablets of dydrogesterone daily

Oral dydrogesterone Group

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy
• Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
• Presence of risk factor for preterm labor:
• Previous spontaneous preterm labor in previous singleton Pregnancy, OR
• Previous spontaneous second trimestric miscarriage less than 3 times, OR
• Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.

You may not qualify if:

• Multiple pregnancy.
• Medical or obstetric conditions requiring termination of pregnancy
• Contraindication to progesterone administration or its use earlier in this pregnancy
• Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
• Liver dysfunction or disease.
• Known or suspected malignancy of breast or genital organs.
• Undiagnosed vaginal bleeding.
• Missed abortion.
• Known sensitivity to progesterone injection.
• Known sensitivity to sesame oil/seeds.
• Congenital fetal anomalies
• Cervical cerclage in the current pregnancy.
• Presence of uterine anomalies (Unicornuate uterus , Uterus didelphys, bicornuate uterus,Septated uterus) or uterine fibroid.
• Presence of history of chronic hypertetion, chronic liver or kidney diseases, and pregnancy induced hypertension.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohamed Samy, MD

  M Samy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Samy, MD

CONTACT

01001947488; mohammedsamy8132@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 25, 2018
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)