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

NCT ID: NCT03779451

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-04-01

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.

Conditions

Placenta Previa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

17-OHPC

Intervention Type: DRUG

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.

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

Group Type: ACTIVE_COMPARATOR

vaginal progesterone

Intervention Type: DRUG

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

17-OHPC

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.

Intervention Type: DRUG

vaginal progesterone

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

Intervention Type: DRUG

Other Intervention Names

Active Comparator; cidolut depot; Active Comparator; Cyclogest

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

01022336052 ext. 002

Facility Contacts

hany f sallam, md

Role: primary

nahla.elsayed@aswu.ed.eg

01092440504 ext. 002

Nahla w Shady, md

Role: backup

nahla.elsayed@aswu.edu.eg

1019240504 ext. 002

Other Identifiers

aswu/191/18

Identifier Type: -

Identifier Source: org_study_id