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

Aswan University Hospital

Status: Unknown

Conditions: Placenta Previa

Treatments: Drug: placebo to 17-OHPC; Drug: 17-OHPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03779438

aswu/189/18

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

17-OHPC

Active Comparator group

Description:

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

Treatment:

Drug: 17-OHPC

placebo to 17-OHPC

Placebo Comparator group

Description:

patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Treatment:

Drug: placebo to 17-OHPC