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

January 21, 2017 updated by: Omar Mamdouh Shaaban, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The progesterone vaginal pessary group
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
Drug: The progesterone vaginal pessary
Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
Other Names:
  • Active drug treatment
Placebo Comparator: Tonics group
Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery
Drug: Tonics group
Those patients will receive only tonics
Other Names:
  • Placepo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of delivery
Time Frame: from 28 weeks till delivery
from 28 weeks till delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mode of delivery
Time Frame: from 28 weeks till delivery
from 28 weeks till delivery
Birth weight
Time Frame: at time of delivery
at time of delivery
The need for neonatal intensive care incubator.
Time Frame: after delivery
after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 15, 2017

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 25, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progesterone vaginal pessary

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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