Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
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|ClinicalTrials.gov Identifier: NCT03130504|
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : July 3, 2018
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%).
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labor||Drug: 17α hydroxy progesterone caproate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
|Active Comparator: 17α hydroxy progesterone caproate group||
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
|No Intervention: No intervention group|
- number of women delivered before 37 weeks [ Time Frame: 13 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130504
|Women Health Hospital - Assiut university|
|Assiut, Egypt, 71111|