NCT03537287

Different Types of Progesterone in the Prevention of Preterm Labor

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	17 alpha hydroxyprogestrone caproate	250 mg of 17 alpha hydroxyprogestrone caproate weekly
DRUG	Vaginal progesterone	200 mg of vaginal progesterone daily
DRUG	Oral dydrogesterone	2 tablets of dydrogesterone daily

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-07-01
• Completion: 2018-08-01
• First posted: 2018-05-25
• Last updated: 2018-05-29

Locations

1 site across 1 country: Egypt