Effect Of Amniotomy In Early Labour On Duration Of Labour In Primigravida At Term Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean duration of labour in amniotomy group and spontaneous rupture of membranes in primigravida at term pregnancy
研究概览
简要总结
The goal of this clinical trial is to learn if intentional rupturing of amniotic sac in early labour works to shorten the duration of labour.
The main question it aims to answer is
. Does the intentional rupture of amniotic sac in early labour lowers the duration of labour in primigravida at term as compared to expectant management.
The researchers will compare mean duration of labor in intentional rupture of amniotic sac in early labour group to expectant management untill spontaneous rupture of amniotic sac in primigravida at term pregnancy.
The participants will be randomly assigned to group A and B through lottery method using sealed opaque envelopes.
In group A, amniotomy at 3cm will be done using aseptic measurements with the help of forcep. while in group B, membranes will be left intact. A partograph will be maintained in all patients throughout labor. Duration of each stage of labour will be monitored as per operational definition by the nurse not aware of treatment given. Fetal and maternal monitoring will be done half hourly till delivery of infant. Cesarean-section will be done in non-reactive CTG patients. In case of any of the adverse events related to intervention like placental abruption and cord prolapse [that is less likely as the subjects are primigravida patients in which head is mostly already engaged before onset of labour], and presence of meconium upon ARM that is not related to intervention individualized care will be provided like continuous electronic fetal monitoring and emergency caserean section will be kept in hand. If any adverse event occur related to intervention it will be reported to IRB within 24hours. All the patients will be kept under observation for 24 hours after delivery. All the data will be recorded on proforma
详细描述
Effect of Amniotomy in Early Labour on Duration of Labour in Primigravida at Term Pregnancy: A Randomized Controlled Trial.
Introduction Labor is a physiological but painful experience for women. It is a dynamic and ongoing process that culminates with the delivery of a healthy baby, followed by the ejection of the placenta and membranes.After active labor has begun, the membranes burst, which is known as spontaneous membrane rupture.Amniotomy is the artificial breach of the amniotic membrane with the primary goal of accelerating contraction and shortening the duration of labor.Studies have shown that amniotomy procedure is very effective to reduce the time duration of labour and maternal risk factors. Amniotomy method is also applied when internal monitoring of fetus is required.
The mechanism of action behind amniotomy is thought to be the release of prostaglandin E2 (PGE2) and rise of oxytocin level.Routine early amniotomy appears to be associated with both benefits and risks. It's typically used to accelerate labour and was originally thought to decrease caesarean section rates. Amniotomy is a frequent and low-cost method of inducing labor. The link between early amniotomy and severe maternal morbidity varied according to maternal factors, while early amniotomy was not linked to newborn morbidity.
The current study has been planned to examine the effect of amniotomy in terms of reducing the time duration of labour in primigravida at term gestation. The study results obtained from our local setting will be useful for expertise while selecting the mode of delivery. Evidence-based guidelines will help in practicing standardize care, reduce variability in practice, reduce maternal and neonatal mortality and improve overall outcomes for mothers and babies.
Objective: To compare mean duration of labor in amniotomy compared to spontaneous rupture of membrane in primigravida at term pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 45 years
- •Primigravida, singleton fetus (on antenatal scan)
- •Full term - gestational age 37 - 41 weeks
- •Established labour (presence of regular uterine contractions - 3 per 10 minutes)
排除标准
- •History of chronic hypertension, diabetes mellitus, gestational diabetes - on medical record
- •Rupture of the membrane (pooling of fluid in vaginal on speculum examination)
- •History of antepartum hemorrhage (history and medical record)
研究组 & 干预措施
Group A-Amniotimy group
amniotomy performed at 3 cm cervical dilatation using aseptic technique
干预措施: Amniotomy (intentional rupture of amniotic sac during labour) (Procedure)
Group B-Expectant group
Membranes left intact untill spontaneous rupture of membranes occur
结局指标
主要结局
Mean duration of labour in amniotomy group and spontaneous rupture of membranes in primigravida at term pregnancy
时间窗: 6 months
To compare the mean duration of labour in primigravida at term pregnancy undergoing amniotomy in early labour at 3-4 cm cervical dilatation versus expectant management until spontaneous rupture of membranes.
次要结局
未报告次要终点
研究者
Bushra Iqbal
Post graduate resident FCPS Gynae & Obs RTEH Muzaffagarh
Indus Hospital and Health Network