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

Last updated: February 14, 2019
Sponsor: Aswan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT03779451
aswu/191/18
  • Ages 18-45
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestational age 26-28 weeks of gestation.

  • Definite and reliable diagnosis of placenta previa (defined as the presence of aplacenta within 2 cm of the internal os), using a transvaginal ultrasound scan

Exclusion

Exclusion Criteria:

  • Multiple pregnancies.

  • Women at high risk of preterm labor e.g. history of spontaneous preterm labor orpreterm 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 whateverreason.

Study Design

Total Participants: 400
Study Start date:
January 01, 2019
Estimated Completion Date:
April 01, 2022

Study 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.

Connect with a study center

  • Aswan University

    Aswan, 81528
    Egypt

    Active - Recruiting

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