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

About this trial
This is an interventional prevention trial for Preterm Birth focused on measuring preterm birth, Twin pregnancy, progesterone
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
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
NCT ID
NCT02350231
First Posted
January 5, 2015
Last Updated
January 21, 2017
Sponsor
Assiut University
Collaborators
Sohag University
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
We'll reach out to this number within 24 hrs