Clinical trial NCT03779438: 17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa
Official title: Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Keywords: cesarean section
placenta previa
antepartum hemorrhage
17-alpha-Hydroxyprogesterone caproate
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-Blind Randomized Clinical Trial
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
timeFrame: 6 weeks
Secondary outcomes:
measure: apgar score
timeFrame: 5 minutes postpartum
measure: the number of patients with postpartum hemorrhage
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: