Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
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
- 否
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
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
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
Omar Mamdouh Shaaban
Professor of Obstetrics and Gynecology
Assiut University
