Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
Primary Purpose
Preterm Labor
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
17α hydroxy progesterone caproate
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Labor
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
17α hydroxy progesterone caproate group
No intervention group
Arm Description
Outcomes
Primary Outcome Measures
number of women delivered before 37 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03130504
Brief Title
Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
Official Title
The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
17α hydroxy progesterone caproate group
Arm Type
Active Comparator
Arm Title
No intervention group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
17α hydroxy progesterone caproate
Intervention Description
where patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks
Primary Outcome Measure Information:
Title
number of women delivered before 37 weeks
Time Frame
13 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
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