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CTRI Number  CTRI/2024/12/078434 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 30/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Implementation of midwife led intrapartum care in a tertiary care hospital 
Scientific Title of Study   Midwife led intrapartum care in a tertiary care teaching hospital: an experimental implementation research 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gowri Dorairajan 
Designation  Professor and Head Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate medical Education and research( JIPMER) 
Address  Professor and Head Obstetrics and Gynecology Women and child Block JIPMER, Dhanvantari Nagar. Puducherry
68 first cross Nanbargal Nagar Reddiyarpalayam Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  04132298131  
Fax    
Email  gowridorai@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gowri Dorairajan 
Designation  Professor and Head Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate medical Education and research( JIPMER) 
Address  Professor and Head Obstetrics and Gynecology Women and child Block JIPMER, Dhanvantari Nagar. Puducherry
68 first cross Nanbargal Nagar Reddiyarpalayam Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  04132298131  
Fax    
Email  gowridorai@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Gowri Dorairajan 
Designation  Professor and Head Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate medical Education and research( JIPMER) 
Address  Professor and Head Obstetrics and Gynecology Women and child Block JIPMER, Dhanvantari Nagar. Puducherry
68 first cross Nanbargal Nagar Reddiyarpalayam Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  04132298131  
Fax    
Email  gowridorai@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi. PIN-110029 
 
Primary Sponsor  
Name  Indian Council of Medical research 
Address  Indian Council of Medical Research. Ansari Nagar. New Delhi. PIN-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gowri Dorairajan  Jawaharlal Institute of Postgraduate education and Research  Professor Room, Department of Obstetrics and Gynaecology, Second Floor. Women and Child Block, Dhanvantari Nagar. Puducherry. PIN-605006
Pondicherry
PONDICHERRY 		 04132298131

gowridorai@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal pregnancy without risk 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Midwife led care for child birth  Strict criteria for inclusion of only low risk women will be generated. The pregnant women attending the antenatal outpatient department at the women and child block will be screened for risk. Phase 1. Reach Outcome. Situation analysis will be done in terms of per-centage of women screened and women willing to participate. Characters of individuals who participated and those who refused will be analyzed by mixed method study. Informed consent will be obtained from the participants. The low risk screened women willing to accept the intervention will receive basic birth education class as per usual practice. Phase 2: Intervention: 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 positions, nonpharmacological pain relief etc. . The likely birth companion (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 development of any new risk. 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. The midwife led group of women will be birthed in an exclusive separate room for natural 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 positions, Robozou, positive affirmations, water birthing, etc. Fetal monitoring will be done with the help of hand held doppler /stethoscope. The internal examination will be minimized to the fewest possible. 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 intramuscular oxytocin injection. The baby will be immediately put skin to skin to mother and golden 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 interventions and women satisfaction will be noted and compared with the rates of similar low risk women in the routine obstetrician led birthing rooms. The duration of this phase of intervention is 30 months  
Comparator Agent  Obstetrician led care during childbirth  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. The duration of this phase is 30 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  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 co Pi Huldah John who is working as an assistant professor on contract basis is also a certified midwife and was conducting mid wife led care in the Institute of Obstetrics and Gynecology Chennai. 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 internal examination will be mini-mized to the fewest possible. 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.


 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  At child birth.
at 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
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
every 6 months
at child birth.
at 36 months  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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