Intramuscular Hydroxyprogesterone Caproate and Placenta Previa

NCT03130504 | Completed Phase 2

• 1 other identifier: IMHC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• number of women delivered before 37 weeks

  13 weeks

Study Arms (2)

17α hydroxy progesterone caproate group

ACTIVE COMPARATOR

Drug: 17α hydroxy progesterone caproate

No intervention group

NO INTERVENTION

Interventions

17α hydroxy progesterone caproate DRUG

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

17α hydroxy progesterone caproate group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Estimated gestational age is ranging between 24 weeks and 26 week's gestation
• Singleton pregnancy.
• Placenta previa; either major or minor degrees.
• Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
• For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
• Accepting to participate in the study.

You may not qualify if:

• Definite rupture of membranes.
• Established preterm labor.
• Severe attack of bleeding requiring an immediate intervention.
• Fetal heart rates instability or non reassuring
• Intrauterine fetal death or major fetal anomalies.
• If associated with abruptio placentae
• Patients with known bleeding disorders or on anticoagulant therapy
• Patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment …etc
• The presence of reported side effects in the mother from 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: April 26, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)