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

Placenta Previa Clinical Trial

Official title:

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03779451
• Other study ID #: aswu/191/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patient delivered before 37 weeks	calculation the number of patients delivered before 37 weeks	2 month
Secondary	number of episodes of antepartum hemorrhage	calculating the mean number of episodes of antepartum hemorrhage	2 month
Secondary	Hospital admission for significant antepartum hemorrhage	Number of patients requiring hospital admission for significant antepartum hemorrhage	2 month
Secondary	Neonatal Birth weight	measure Neonatal Birth weight in kilograms	one hours post operative