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Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth (PPPTP)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
The progesterone vaginal pessary
Tonics group
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring preterm birth, Twin pregnancy, progesterone

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diamniotic twin pregnancy
  2. Gestational age ± 28 weeks.

Exclusion Criteria:

  1. Higher multiple pregnancy
  2. IUFD of one or both fetuses
  3. Any congenital anomalies
  4. IUGR or discordant twins
  5. PROM
  6. If there is any contraindication to progesterone treatment
  7. Women who did performed cervical cerclage in the current pregnancy
  8. Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).
  9. Threatened preterm labor.
  10. Polyhydromnis.
  11. Other medical disorder with pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    The progesterone vaginal pessary group

    Tonics group

    Arm Description

    Where they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium

    Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery

    Outcomes

    Primary Outcome Measures

    Time of delivery

    Secondary Outcome Measures

    Mode of delivery
    Birth weight
    The need for neonatal intensive care incubator.

    Full Information

    First Posted
    January 5, 2015
    Last Updated
    January 21, 2017
    Sponsor
    Assiut University
    Collaborators
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02350231
    Brief Title
    Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
    Acronym
    PPPTP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University
    Collaborators
    Sohag University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States. Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy. Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone. Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth
    Keywords
    preterm birth, Twin pregnancy, progesterone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The progesterone vaginal pessary group
    Arm Type
    Active Comparator
    Arm Description
    Where they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium
    Arm Title
    Tonics group
    Arm Type
    Placebo Comparator
    Arm Description
    Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery
    Intervention Type
    Drug
    Intervention Name(s)
    The progesterone vaginal pessary
    Other Intervention Name(s)
    Active drug treatment
    Intervention Description
    Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
    Intervention Type
    Drug
    Intervention Name(s)
    Tonics group
    Other Intervention Name(s)
    Placepo
    Intervention Description
    Those patients will receive only tonics
    Primary Outcome Measure Information:
    Title
    Time of delivery
    Time Frame
    from 28 weeks till delivery
    Secondary Outcome Measure Information:
    Title
    Mode of delivery
    Time Frame
    from 28 weeks till delivery
    Title
    Birth weight
    Time Frame
    at time of delivery
    Title
    The need for neonatal intensive care incubator.
    Time Frame
    after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diamniotic twin pregnancy Gestational age ± 28 weeks. Exclusion Criteria: Higher multiple pregnancy IUFD of one or both fetuses Any congenital anomalies IUGR or discordant twins PROM If there is any contraindication to progesterone treatment Women who did performed cervical cerclage in the current pregnancy Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc). Threatened preterm labor. Polyhydromnis. Other medical disorder with pregnancy

    12. IPD Sharing Statement

    Learn more about this trial

    Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

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