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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    400
  • sponsor
    Aswan University Hospital
Updated on 22 January 2021

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

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.

Details
Condition Placenta Previa
Treatment Vaginal progesterone, 17-OHPC
Clinical Study IdentifierNCT03779451
SponsorAswan University Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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