Different Types of Progesterone in the Prevention of Preterm Labor

Preterm Labor Clinical Trial

Official title:

Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03537287
• Other study ID #: PDPTL
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: May 2018
• Source: Ain Shams University
• Contact: Mohamed Samy, MD
• Phone: 01001947488
• Email: mohammedsamy8132[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• 17 alpha hydroxyprogestrone caproate
250 mg of 17 alpha hydroxyprogestrone caproate weekly
• Vaginal progesterone
200 mg of vaginal progesterone daily
• Oral dydrogesterone
2 tablets of dydrogesterone daily

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemodynamic changes in fetoplacental circulation	Measurement of U/S Doppler indices of umbilical artery and middle cerebral artery (namely PI, RI and S/D ratio) in fetal circulation	6 months
Secondary	Unsatisfactory response	Number of patients who needed to increase the dose above the recommended initial dose.	6 months
Secondary	Failure of prevention of preterm labor	Number of patients who suffered preterm labor and needed tocolysis	6 months
Secondary	Birth weight	Birth weight in Kg	6 months
Secondary	Neonatal APGAR score	Neonatal Apgar score at 1 and 5 min.	6 months
Secondary	Need for NICU admission	Number of patients whose neonates were admitted to NICU; Neonatal mortality.	6 months
Secondary	Neonatal mortality	Number of neonatal deaths	6 months