Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Different Types of Progesterone in the Prevention of Preterm Labor

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537287
Recruitment Status : Unknown
Verified May 2018 by mohammed mahmoud samy, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : May 25, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
mohammed mahmoud samy, Ain Shams University

Brief Summary:

Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life..

There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women


Condition or disease Intervention/treatment Phase
Preterm Labor Drug: 17 alpha hydroxyprogestrone caproate Drug: Vaginal progesterone Drug: Oral dydrogesterone Phase 2

Detailed Description:

This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.

All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.

The study population will be randomly distributed according to the mode of intervention into 3 groups.

Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained

Group 1:

Women who will take intramuscular 17 alpha hydroxyprogestrone caproate

Dose:

250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.

Group 2 :

Women who will take progesterone 200mg vaginal suppositories.

Dose:

Once per day starting from 16 weeks till delivery or 36 weeks

Group 3 :

Women who will take oral dydrogesterone

Dose:

Take 2 tablets a day starting from 16 weeks till delivery or 36 weeks

Color Doppler blood flow velocity examination of fetal circulation will be performed by an independent investigator blinded to treatment before treatment &after two weeks of treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 17 alpha hydroxyprogestrone caproate Group
Patients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks.
Drug: 17 alpha hydroxyprogestrone caproate
250 mg of 17 alpha hydroxyprogestrone caproate weekly

Active Comparator: Vaginal progesterone Group
Patients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks.
Drug: Vaginal progesterone
200 mg of vaginal progesterone daily

Active Comparator: Oral dydrogesterone Group
Patients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks
Drug: Oral dydrogesterone
2 tablets of dydrogesterone daily




Primary Outcome Measures :
  1. Gestational age in weeks at delivery. [ Time Frame: 6 months ]
    using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery


Secondary Outcome Measures :
  1. Hemodynamic changes in fetoplacental circulation [ Time Frame: 6 months ]
    Measurement of U/S Doppler indices of umbilical artery and middle cerebral artery (namely PI, RI and S/D ratio) in fetal circulation

  2. Unsatisfactory response [ Time Frame: 6 months ]
    Number of patients who needed to increase the dose above the recommended initial dose.

  3. Failure of prevention of preterm labor [ Time Frame: 6 months ]
    Number of patients who suffered preterm labor and needed tocolysis

  4. Birth weight [ Time Frame: 6 months ]
    Birth weight in Kg

  5. Neonatal APGAR score [ Time Frame: 6 months ]
    Neonatal Apgar score at 1 and 5 min.

  6. Need for NICU admission [ Time Frame: 6 months ]

    Number of patients whose neonates were admitted to NICU

    Neonatal mortality.


  7. Neonatal mortality [ Time Frame: 6 months ]
    Number of neonatal deaths



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:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
  • Presence of risk factor for preterm labor:

    1. Previous spontaneous preterm labor in previous singleton Pregnancy, OR
    2. Previous spontaneous second trimestric miscarriage less than 3 times, OR
    3. Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.

Exclusion Criteria:

  • Multiple pregnancy.
  • Medical or obstetric conditions requiring termination of pregnancy
  • Contraindication to progesterone administration or its use earlier in this pregnancy

    • Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
    • Liver dysfunction or disease.
    • Known or suspected malignancy of breast or genital organs.
    • Undiagnosed vaginal bleeding.
    • Missed abortion.
    • Known sensitivity to progesterone injection.
    • Known sensitivity to sesame oil/seeds.
  • Congenital fetal anomalies
  • Cervical cerclage in the current pregnancy.
  • Presence of uterine anomalies (Unicornuate uterus , Uterus didelphys, bicornuate uterus,Septated uterus) or uterine fibroid.
  • Presence of history of chronic hypertetion, chronic liver or kidney diseases, and pregnancy induced hypertension.

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): NCT03537287


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
Contact: Mohamed Samy, MD         
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: NCT03537287    
Other Study ID Numbers: PDPTL
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs