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Completed

NCT Number: NCT02350231

Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The progesterone vaginal pessary

Drug

Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy

Other names: Active drug treatment

Tonics group

Drug

Those patients will receive only tonics

Other names: Placepo

Primary outcomes

  1. Time of delivery

    Time frame: from 28 weeks till delivery

Secondary outcomes

  1. Mode of delivery

    Time frame: from 28 weeks till delivery

  2. Birth weight

    Time frame: at time of delivery

  3. The need for neonatal intensive care incubator.

    Time frame: after delivery

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Sohag University

Registry information

Acronym: PPPTP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2015
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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