17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

Placenta Previa Clinical Trial

Official title:

Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03779438
• Other study ID #: aswu/189/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

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

Clinical Trial Summary

Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa

Description:

Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.

Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.

The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 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:

• Estimated gestational age: between 24 weeks and 37 week's gestation

• Confirmed Placenta previa; either major or minor degrees.

• Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding

Exclusion Criteria:

• Severe attack of bleeding requiring an immediate intervention.

• Fetal heart rates instability or non-reassuring tracing

• Intrauterine fetal death or major fetal anomalies.

• If associated with abruptio placentae

• Patients with known bleeding disorders or on anticoagulant therapy

• Patients with severe medical disorders

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Drug:
• 17-OHPC
patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
• placebo to 17-OHPC
patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' 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	the duration of prolongation of pregnancy from the time of enrollment to the time of delivery	measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery	6 weeks
Secondary	apgar score	measure apgar score from 0 to 10	5 minutes postpartum
Secondary	the number of patients with postpartum hemorrhage	calculation the number of patients with postpartum hemorrhage	24 hours post operative