Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.
研究概览
简要总结
In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity.
According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.
Single-centre, randomised, open-label, 3-arm study :
Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women.
Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.
Control group: no specific dietary advice. Routine care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •Age ≥ 18 years
- •Nulliparous
- •Single pregnancy with fetus in cephalic presentation
- •Pregnancy with physiological course
- •Gestational age ≥ 34 and ⩽ 37 SA
- •Membership of a social security scheme (CMU accepted)
- •Signed informed consent
排除标准
- •Any contraindication to vaginal delivery
- •Presence of a foetal malformation
- •Diabetes of any type (1, 2 or gestational)
- •Food allergy contraindicating participation in the study
- •Illiterate or non-French-speaking women
- •Women under guardianship or trusteeship
研究组 & 干预措施
dietary advice + food supplied
Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need.
干预措施: dietary advice (Other)
dietary advice + food supplied
Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need.
干预措施: food supplied (Other)
dietary advice alone
Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.
干预措施: dietary advice alone (Other)
usual care
No specific dietary advice
结局指标
主要结局
Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.
时间窗: From 37 weeks'amenorrhoea to delivery (up to 41 weeks)
次要结局
- Evaluation of women's experience of the intervention using a post-partum questionnaire(Following childbirth, during the stay in the maternity ward ; assessed up to 5 days)