Different Types of Progesterone in the Prevention of Preterm Labor

NCT ID: NCT03537287

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-08-31

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

Detailed Description

This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.

All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.

The study population will be randomly distributed according to the mode of intervention into 3 groups.

Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained

Group 1:

Women who will take intramuscular 17 alpha hydroxyprogestrone caproate

Dose:

250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.

Group 2 :

Women who will take progesterone 200mg vaginal suppositories.

Dose:

Once per day starting from 16 weeks till delivery or 36 weeks

Group 3 :

Women who will take oral dydrogesterone

Dose:

Take 2 tablets a day starting from 16 weeks till delivery or 36 weeks

Color Doppler blood flow velocity examination of fetal circulation will be performed by an independent investigator blinded to treatment before treatment &after two weeks of treatment.

Conditions

Preterm Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

17 alpha hydroxyprogestrone caproate Group

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

Group Type: ACTIVE_COMPARATOR

17 alpha hydroxyprogestrone caproate

Intervention Type: DRUG

250 mg of 17 alpha hydroxyprogestrone caproate weekly

Vaginal progesterone Group

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

Group Type: ACTIVE_COMPARATOR

Vaginal progesterone

Intervention Type: DRUG

200 mg of vaginal progesterone daily

Oral dydrogesterone Group

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

Group Type: ACTIVE_COMPARATOR

Oral dydrogesterone

Intervention Type: DRUG

2 tablets of dydrogesterone daily

Interventions

17 alpha hydroxyprogestrone caproate

250 mg of 17 alpha hydroxyprogestrone caproate weekly

Intervention Type: DRUG

Vaginal progesterone

200 mg of vaginal progesterone daily

Intervention Type: DRUG

Oral dydrogesterone

2 tablets of dydrogesterone daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. Previous spontaneous preterm labor in previous singleton Pregnancy, OR

2. Previous spontaneous second trimestric miscarriage less than 3 times, OR

3. Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

mohammed mahmoud samy

Lecturer in Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Samy, MD

Role: PRINCIPAL_INVESTIGATOR

M Samy

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Samy, MD

Role: CONTACT

mohammedsamy8132@gmail.com

01001947488

Facility Contacts

Mohamed Samy, MD

Role: primary

Other Identifiers

PDPTL

Identifier Type: -

Identifier Source: org_study_id