Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Not Applicable

• Conditions: Placenta Previa
• Interventions: Drug: vaginal progesterone; Drug: 17-OHPC

• Registration Number: NCT03779451
• Lead Sponsor: Aswan University Hospital

Brief Summary

Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

Detailed Description

The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.

Study Timeline

• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-15
• Study First Posted: 2018-12-19
• Study Start: 2019-01-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Gestational age 26-28 weeks of gestation.
• Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan

Exclusion Criteria

• Multiple pregnancies.
• Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour rupture of the membranes (PPROM).
• Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent -intervention and delivery.
• Women who have been maintained on progestin therapy since early pregnancy for whatever reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginal progesterone	vaginal progesterone	vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery
17-OHPC	17-OHPC	patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery

Primary Outcome Measures

Name	Time	Method
number of patient delivered before 37 weeks	2 month	calculation the number of patients delivered before 37 weeks

Secondary Outcome Measures

Name	Time	Method
number of episodes of antepartum hemorrhage	2 month	calculating the mean number of episodes of antepartum hemorrhage
Hospital admission for significant antepartum hemorrhage	2 month	Number of patients requiring hospital admission for significant antepartum hemorrhage
Neonatal Birth weight	one hours post operative	measure Neonatal Birth weight in kilograms

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt