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临床试验/NCT02350231
NCT02350231已完成2 期

Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Assiut University0 个研究点目标入组 100 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
主要终点
Time of delivery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diamniotic twin pregnancy
  • Gestational age ± 28 weeks.

排除标准

  • Higher multiple pregnancy
  • IUFD of one or both fetuses
  • Any congenital anomalies
  • IUGR or discordant twins
  • 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

研究组 & 干预措施

The progesterone vaginal pessary group

Active Comparator

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

干预措施: The progesterone vaginal pessary (Drug)

Tonics group

Placebo Comparator

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

干预措施: Tonics group (Drug)

结局指标

主要结局

Time of delivery

时间窗: from 28 weeks till delivery

次要结局

  • Mode of delivery(from 28 weeks till delivery)
  • Birth weight(at time of delivery)
  • The need for neonatal intensive care incubator.(after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Mamdouh Shaaban

Professor of Obstetrics and Gynecology

Assiut University

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