NCT03130504

Intramuscular Hydroxyprogesterone Caproate and Placenta Previa

The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide. Placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries. Many studies in literature proved the positive correlation between the Placenta previa and preterm uterine contractility and also reported that large proportion of women who have Placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding. There are many tocolytic agents may have a role in conservative management of Placenta previa such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus 54.9%).

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	17α hydroxy progesterone caproate	where patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2017-04-26
• Last updated: 2018-07-03

Locations

1 site across 1 country: Egypt