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Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth (prematurity)

Primary Purpose

Preterm Birth

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin tablet
Placebo
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women of any age
  2. Any parity
  3. Healthy singleton pregnancy
  4. History suggestive of one or more previous PTB
  5. Current pregnancy (16-20) weeks gestation.

Exclusion Criteria:

  1. Multifetal pregnancy.
  2. History of ante partum PROM.
  3. Cervical Incompetence or current cervical cerclage.
  4. Known fetal anomaly.
  5. Hypertension requiring medications.
  6. History of Thrombo-embolic disorders.
  7. Known allergy to progesterone or asprin.
  8. Known liver disease.
  9. Established preterm labor
  10. Short cervix

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Progesterone with asprin

    Progesterone and placebo

    Arm Description

    The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),

    vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

    Outcomes

    Primary Outcome Measures

    Number of participants who will deliver before 34 weeks gestation.
    Number of participants who have preterm delivery before 34 weeks gestation

    Secondary Outcome Measures

    The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
    Number of participants who will deliver after 34w gestation and neonatal outcomes
    Neonatal outcomes
    Neonatal birth weight Admission to NICU Neonatal complications

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    March 31, 2022
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05319834
    Brief Title
    Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
    Acronym
    prematurity
    Official Title
    Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
    Detailed Description
    The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    All participants and investigators
    Allocation
    Randomized
    Enrollment
    254 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Progesterone with asprin
    Arm Type
    Active Comparator
    Arm Description
    The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),
    Arm Title
    Progesterone and placebo
    Arm Type
    Placebo Comparator
    Arm Description
    vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin tablet
    Other Intervention Name(s)
    group 1 intervention
    Intervention Description
    group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    group 2 intervention
    Intervention Description
    group 2: oral placebo once daily at the same time with progesterone
    Primary Outcome Measure Information:
    Title
    Number of participants who will deliver before 34 weeks gestation.
    Description
    Number of participants who have preterm delivery before 34 weeks gestation
    Time Frame
    18 month
    Secondary Outcome Measure Information:
    Title
    The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
    Description
    Number of participants who will deliver after 34w gestation and neonatal outcomes
    Time Frame
    18 months
    Title
    Neonatal outcomes
    Description
    Neonatal birth weight Admission to NICU Neonatal complications
    Time Frame
    18 months

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women of any age Any parity Healthy singleton pregnancy History suggestive of one or more previous PTB Current pregnancy (16-20) weeks gestation. Exclusion Criteria: Multifetal pregnancy. History of ante partum PROM. Cervical Incompetence or current cervical cerclage. Known fetal anomaly. Hypertension requiring medications. History of Thrombo-embolic disorders. Known allergy to progesterone or asprin. Known liver disease. Established preterm labor Short cervix

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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