CTRI/2024/12/078434招募中1 期
Midwife led intrapartum care in a tertiary care teaching hospital: an experimental implementation research
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the rates of episiotomy and women satisfac-tion between mid-wife led and obstetrician led intrapar-tum care in a tertiary care teaching hospital.
研究概览
简要总结
This trial is being carried out at a tertiary care teaching Institute to study the challenges, barriers, adherence and the effectiveness of midwife led care in comparison to obstetrician led care during childbirth among women with lor risk pregnancy. We wish to carry out the study by determining the reach outcome, the effectiveness of the intervention in reducing episiotomy and caesarean rates. we will also study the barriers in adoption and fidelity of the midwife led care implemented. We will further study the likelihood of maintenance of this service of midwife led care during child birth in a tertiary care teaching hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women between 18-35 years with Low risk as screened by obstetric and mid-wife team getting into spontaneous labor and those who have undergone structured birth-ing classes during pregnancy and those willing to go through natural birthing as defined in introduction will be included.They will be thereafter randomized to the usual obstetrician led care or the midwife led care group at 32 weeks.
- •The midwife care led group will be given regular birth education classes along with their birth companions with video assisted teaching on alternate birth posi-tions, nonpharmacological pain relief etc.
- •The husbands of the woman can attend the birthing class.
- •The classes will be held together in small groups of 4 couples as well as separately for husbands alone by the birth educator.
- •The likely birth com-panion (who will be present at delivery) must attend the birth education classes.
- •At term and in Labor, the women in the two groups will be reassessed for the devel-opment of any new risk like prolonged leaking, fever, abnormal fetal heart rate pattern, meconium or blood stained liquor and need for oxytocin augmentation, prolonged labour or second stage.
- •If yes, they would be excluded from per proto-col analysis but included in the intention to treat analysis.
- •If no they will continue to follow the protocol.
- •We will try to complete the sample size for the protocol analysis.
- •Definition of Midwife for the study:There are four nursing officers who have been trained and certified at Fernandez Hospital with midwife intrapartum care.
- •The recruited nurses will also be trained in house under the mentorship of certified trainers for midwife led care during preg-nancy and during child birth process.
- •The midwife led group of women will be birthed in an exclusive separate room for nat-ural birthing by certified trained midwives guided and supervised by the PI.
- •Pain relief will be given by alternate methods like back massage, hot fomentation, alternate posi-tions, Robozou, positive affirmations, water birthing, etc.
- •Fetal monitoring will be done with the help of hand held doppler /stethoscope.
- •The women will be ambulated and allowed to listen to mu-sic/ assume position of her choice during labour.
- •Birth companion ( who attended the birth education classes with her) will be allowed through out labour.
- •Second stage will be managed in the position preferred by the women.
- •Perineal massages and hot fomentation will be done to give pain relief.
- •Birthing will be conducted by a trained/certified midwife nurse with good perineal support without episiotomy.
- •Active management of the third stage of labor will be offered for all with 10 units of intramuscu-lar oxytocin injection.
- •The baby will be immediately put skin to skin to mother and gold-en hour of non-separation will be followed.
- •Intrapartum rescue will be done by a team of obstetricians on duty in consultation and if need be led by the PI, if the need arises.
- •The rates of episiotomy and other medical inter-ventions and women satisfaction will be noted and compared with the rates of similar low risk women in the routine obstetrician led birthing rooms.
排除标准
- •Multiple preganncy.
- •Previous cesarean pregancy even if no other risk.
- •The obstetrican led group will labour in the common labour room.
- •They will be allowed birth companion, positions of their choice and pain relief as per their need.
- •Fetal heart rate monitoring and other intrapartum care will be done as per standard protocol.
结局指标
主要结局
To compare the rates of episiotomy and women satisfac-tion between mid-wife led and obstetrician led intrapar-tum care in a tertiary care teaching hospital.
时间窗: At child birth. | at 6 weeks.
次要结局
- Study of acceptability, adoption, adherence to implementation of midwife led care in tertiary care teaching hospi-tal. Study of cesarean section rates & neonatal outcomes in the two groups.(Baseline)
研究者
Gowri Dorairajan
Jawaharlal Institute of Postgraduate medical Education and research( JIPMER)
研究点 (1)
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