Different Types of Progesterone in the Prevention of Preterm Labor

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Dydrogesterone; Progesterone

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.