Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Study Overview
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Brief Summary
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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.

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: The progesterone vaginal pessary
* Drug: Tonics group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of delivery |  | from 28 weeks till delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm birth, Twin pregnancy, progesterone