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

Aswan University Hospital

Status: Unknown

Conditions: Placenta Previa

Treatments: Drug: 17-OHPC; Drug: vaginal progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03779451

aswu/191/18

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

17-OHPC

Active Comparator group

Description:

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

Treatment:

Drug: 17-OHPC

vaginal progesterone

Active Comparator group

Description:

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

Treatment:

Drug: vaginal progesterone

control group

No Intervention group

Description:

Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.