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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
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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%).


Condition or disease Intervention/treatment Phase
Preterm Labor Drug: 17α hydroxy progesterone caproate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


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



Primary Outcome Measures :
  1. number of women delivered before 37 weeks [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03130504     History of Changes
Other Study ID Numbers: IMHC
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Obstetric Labor, Premature
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists