Intramuscular Hydroxyprogesterone Caproate and Placenta Previa

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

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%).

Study Overview

• Status: Completed
• Conditions: Preterm Labor
• Intervention / Treatment: Drug: 17α hydroxy progesterone caproate

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of women delivered before 37 weeks	13 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 22, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 30, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Obstetric Labor, Premature; Placenta Previa; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Progestins; Progesterone; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
• Other Study ID Numbers: IMHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No