Intramuscular Hydroxyprogesterone Caproate and Placenta Previa

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130504
• Other study ID #: IMHC
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2016
• Est. completion date: April 2017

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Estimated gestational age is ranging between 24 weeks and 26 week's gestation

2. Singleton pregnancy.

3. Placenta previa; either major or minor degrees.

4. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.

5. For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.

6. Accepting to participate in the study.

Exclusion Criteria:

1. Definite rupture of membranes.

2. Established preterm labor.

3. Severe attack of bleeding requiring an immediate intervention.

4. Fetal heart rates instability or non reassuring

5. Intrauterine fetal death or major fetal anomalies.

6. If associated with abruptio placentae

7. Patients with known bleeding disorders or on anticoagulant therapy

8. Patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment …etc

9. The presence of reported side effects in the mother from 17a hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Placenta Previa
• Preterm Labor

Intervention

Drug:
• 17a hydroxy progesterone caproate
where patients will have a 17a hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of women delivered before 37 weeks		13 weeks