Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    "Placenta Praevia" | "Hormone Antagonists"
Previous Study | Return to List | Next Study

Progesterone in Patients With Placenta Previa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633175
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
mohammed mahmoud samy, Ain Shams University

Brief Summary:
This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.

Condition or disease Intervention/treatment Phase
Placenta Previa Drug: Vaginal progesterone Phase 2

Detailed Description:
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vaginal progesterone group
Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer).
Drug: Vaginal progesterone
400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer).
Other Name: Prontogest® suppositories

No Intervention: Control group
Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.



Primary Outcome Measures :
  1. Incidence of preterm delivery due to severe antepartum hemorrhage. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients who delivered before 37 weeks gestational age


Secondary Outcome Measures :
  1. No. of episodes of antepartum hemorrhage. [ Time Frame: from 26 weeks till 37 weeks ]
    Mean number of episodes of antepartum hemorrhage

  2. Hospital admission for significant antepartum hemorrhage. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients requiring hospital admission for significant antepartum hemorrhage

  3. Hospital admission for threatened preterm labor. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients requiring hospital admission for threatened preterm labor

  4. Need for blood transfusion. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients requiring blood transfusion

  5. Incidence of severe postpartum hemorrhage. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients who had severe postpartum hemorrhage

  6. Incidence of Cesarean hysterectomy. [ Time Frame: from 26 weeks till 37 weeks ]
    Number of patients who underwent cesarean hysterectomy

  7. Patient compliance [ Time Frame: from 26 weeks till 37 weeks ]
    measured as mean number of doses of vaginal progesterone missed per week

  8. Patient satisfaction: Likert Scale [ Time Frame: from 26 weeks till 37 weeks ]
    measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied.

  9. Neonatal Birth weight. [ Time Frame: At birth ]
    measured in Kg

  10. Need for NICU admission and its duration. [ Time Frame: At birth ]
    Number of neonates needing NICU admission

  11. Respiratory morbidity (transient tachypnea or respiratory distress syndrome). [ Time Frame: At birth ]
    number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).

  12. Prematurity-related mortality. [ Time Frame: 28 days postpartum ]
    Number of neonates dying due to prematurity-related cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age 26-28 weeks of gestation.
  2. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.

Exclusion Criteria:

  1. Multiple pregnancy.
  2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
  3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
  4. Women who have been maintained on progestin therapy since early pregnancy for whatever reason.

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): NCT03633175


Contacts
Layout table for location contacts
Contact: Mohamed Samy, MD 01001947488 mohammedsamy8132@gmail.com

Locations
Layout table for location information
Egypt
Ain SHams Maternity Hospital Recruiting
Cairo, Abbaseya, Egypt, 002
Contact: Mohamed Samy, MD    01001947488    mohammedsamy8132@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Samy, MD M Samy

Layout table for additonal information
Responsible Party: mohammed mahmoud samy, Lecturer in Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03633175     History of Changes
Other Study ID Numbers: progesterone
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs