CTRI Number	CTRI/2021/01/030695 [Registered on: 22/01/2021] Trial Registered Prospectively
Last Modified On:	29/08/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Diagnostic Preventive Screening Process of Care Changes Behavioral
Study Design	Other
Public Title of Study	Labour Care Guide Trial for reducing Caesarean Section in India
Scientific Title of Study	Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: a pragmatic, stepped wedge, cluster randomized pilot trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Shivaprasad S Goudar  Address  Department of Physiology KAHERs J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum Belgaum KARNATAKA 590010 India  Phone  9448126371   Fax  8312472891   Email  sgoudar@jnmc.edu
Details Contact Person Scientific Query	Name  Dr Yeshita V Pujar  Address  Department of OBGYN, First floor KAHERs J N Medical College Nehru Nagar Belgaum Belgaum KARNATAKA 590010 India  Phone  9448142989   Fax  8312472891   Email  yvpujar@hotmail.com
Details Contact Person Public Query	Name  Dr Yeshita V Pujar  Address  Department of OBGYN, First floor KAHERs J N Medical College Nehru Nagar Belgaum KARNATAKA 590010 India  Phone  9448142989   Fax  8312472891   Email  yvpujar@hotmail.com
Source of Monetary or Material Support Modification(s)	KLE Academy of Higher Education and Research (Deemed-to-be-University) Belagavi
Primary Sponsor	Name  Bill Melinda Gates Foundation  Address  440 5th Ave N. Seattle, WA 98109 USA  Type of Sponsor  Other [Charitable Foundation]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 4   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Jayashree A K  Gadag Institute of Medical sciences and Hospital  Department of OBGYN, SH 6, Malasamudra, Gadag 582103 Belgaum   9480384328 jayashreeashokkumar@gmail.com  Dr Raveendra Anteen  General Hospital, Gokak, Belagavi.  Chief Medical Officer, Maternal and Child Block, Taluka Hospital, Gokak Belgaum   9743310006 anteendrraveendra@yahoo.com  Dr Suman S Gaddi  Vijayanagar Institute of Medical Sciences and Hospital  Department of OBGYN, Vijaya Nagar, Cantonment, Ballari, 583104 Belgaum   9880190927 yourashirwad@gmail.com  Dr Shukla Shetty  Women and Child Hospital affiliated to JJM Medical College, Davanagere  Department of OBGYN, JJM Medical College, Medical College Rd, MCC B Block, Kuvempu Nagar, Davanagere Belgaum   9945459000 shukla.shetty@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 4   Name of Committee  Approval Status  Institutional Ethics Committee JJM Medical College Davangere  Approved  Institutional Ethics Committee, Gadag Institute of Medical Sciences and Hospital  Approved  Institutional Ethics Committee, KLE Academy of Higher Education and Research, Belagavi  Approved  Institutional Ethics Committee, Vijayanagara Institute of Medical Sciences and Hospital  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Encounter for screening, unspecified
Intervention / Comparator Agent	Type  Name  Details  Intervention  Co-designed implementation strategy targeting healthcare providers to improve intrapartum care  The strategy will target the use of the LCG by maternity care providers, as well as promoting audit and feedback using the Robson Classification.   Comparator Agent  Control: Standard of care  Usual care with dissemination of the WHO 2018 intrapartum care guideline.
Inclusion Criteria	Age From  18.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  Cluster: Health facility is the randomization unit. Participating clusters (formative phase and trial phase) are four public hospitals in India. Across these hospitals, the mean CS rate is ≥30% Healthcare providers attending childbirth will be the target of the intervention.
ExclusionCriteria	Details  Facilities with C Section rate less than 30%
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome Modification(s)	Outcome  TimePoints  Use of CS amongst women in Robson Group 1 (i.e. women who are nulliparous, singleton, cephalic, ≥37 weeks’ gestation, in spontaneous labour).   At discharge from the facility
Secondary Outcome Modification(s)	Outcome  TimePoints  Fetal / Neonatal outcomes 1. Antepartum stillbirth (Fetal death prior to admission) 2. Intrapartum stillbirth 3. Neonatal death (Neonatal death in a liveborn infant by day 7 or discharge, whichever came first)   At discharge from the facility  Maternal outcomes 1. CS rate in women in Robson Groups 1 and 2 2. CS rate in women in Robson Groups 1 to 5 3. Overall CS rate 4. Augmentation with oxytocin during labour rate 5. Early artificial rupture of the membranes rate 6. Episiotomy rate 7. Operative vaginal birth rate 8. Duration of hospital admission  At discharge from the facility  Women’s experience outcomes 1. Woman’s experience with labour companion 2. Woman’s experience of coping with pain 3. Woman’s experience of offering oral fluids 4. Woman’s experience of mobilising during labour 5. Woman’s experience of birth position of choice 6. Woman’s experience of time health worker spent with them 7. Woman’s experience of privacy 8. Woman’s overall experience of care   At discharge from the facility
Target Sample Size	Total Sample Size="25000" Sample Size from India="25000"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	01/03/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Closed to Recruitment of Participants
Publication Details Modification(s)	NIL
Brief Summary Modification(s)	Background: The WHO Labour Care Guide (LCG) is a clinical tool that reflects WHO’s latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine care requires a strategy that effectively improves healthcare provider practices around intrapartum care. Such a strategy may optimize the use of Caesarean section, along with other health and women’s experience of care outcomes. However, the effects of such a strategy have not been evaluated in a randomised trial.  This study aims to: 1. Develop and optimise a strategy for implementing the LCG (formative phase) 2. To evaluate the implementation of the LCG strategy compared with usual care (pilot trial phase) Primary objective: 1.       Evaluate the effect of operationalisation of the LCG implementation strategy on CS rate amongst women in Robson Group 1  Secondary objectives: 2.       2. Evaluate the effect of the LCG implementation strategy on women’s health and process of care outcomes and women’s experiences of care 3.      3. Conduct a process evaluation on the implementation of the LCG strategy  Study design: stepped-wedge, cluster-randomized controlled pilot trial. Setting: Four public hospitals in India. Population: Cluster: Health facility is the randomization unit. Healthcare providers attending childbirth will be the target of the intervention. Intervention: Co-designed implementation strategy targeting healthcare providers to improve intrapartum care. Control: Usual care (use of simplified partograph). Outcomes  Primary outcome The primary outcome is the use of CS amongst women in Robson Group 1 (i.e. women who are nulliparous, singleton, cephalic, ≥37 weeks’ gestation, in spontaneous labour).  Secondary Outcomes Category Outcome Outcome definition Maternal outcomes CS rate in women in Robson Groups 1 and 3 Numerator: Number of women undergoing CS Denominator: Number of women in Robson Groups 1 and 2 CS rate in women in Robson Groups 1 to 5 Numerator: Number of women undergoing CS Denominator: Number of women in Robson Groups 1 to 5 Overall CS rate Numerator: Number of women undergoing CS Denominator: Number of women giving birth Augmentation with oxytocin during labour rate Numerator: Number of women given oxytocin for augmentation during labour Denominator: number of women who experienced spontaneous labour Artificial rupture of the membranes rate Numerator: Number of women who had artificial rupture of membranes Denominator: number of women who experienced spontaneous labour Episiotomy rate Numerator: Number of women who had episiotomy Denominator: number of women with vaginal birth Operative vaginal birth rate Numerator: Number of women who had operative vaginal birth (forceps or vacuum) Denominator: number of women with vaginal birth Duration of hospital admission Total length (hours) of hospital admission for childbirth 3rd or 4th degree tears Numerator: Number of women experiencing 3rd or 4th degree tears Denominator: number of women giving birth PPH requiring uterine balloon tamponade or surgical intervention Numerator: Number of women requiring uterine balloon tamponade OR surgical intervention for PPH Denominator: number of women giving birth Suspected or confirmed maternal infection requiring therapeutic antibiotics Numerator: Number of women with clinical signs or symptoms of maternal infection AND therapeutic antibiotics were required Denominator: number of women giving birth Fetal / Neonatal outcomes Antepartum stillbirth Numerator: Fetal death prior to admission Denominator: All born babies Intrapartum stillbirth Numerator: Fetal death after admission Denominator: All born babies Apgar score <7 at 5 minutes Numerator: Liveborn babies with Apgar <7 at 5 minutes Denominator: Liveborn babies Bag and mask ventilation of newborn Numerator: Use of continuous bag and mask ventilation of newborn for >1 minute Denominator: liveborn babies Mechanical ventilation of newborn Numerator: Use of mechanical ventilation of newborn Denominator: liveborn babies Prolonged (>48 hour) admission in NICU Numerator: Admission to NICU for >48 hours Denominator: liveborn babies Newborns requiring NICU admission for hypoxic ischaemic encephalopathy Numerator: Admission to NICU for suspected or confirmed Denominator: liveborn babies Neonatal death Numerator: Neonatal death in a liveborn infant by day 7 or discharge (whichever came first) Denominator: all liveborn babies Women’s experience outcomes Woman’s experience with labour companion Numerator: Women who reported a labour companion was present during labour or birth Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of being offered pain relief (2 outcomes) Numerator: women who reported that they were asked whether they would like any pain relief Denominator: Women in Robson Group 1 or 3 who complete postpartum survey   Numerator: Women who reported being very satisfied or somewhat satisfied with how their pain was managed during labour and birth Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of being encouraged to drink oral fluids Numerator: Women who reported that a health worker encouraged them to drink water Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of being encouraged to eat food Numerator: Women who reported that a health worker encouraged them to eat food Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of mobilising during labour Numerator: Women who reported that a health worker encouraged them to walk around during labour Denominator: Women in Robson Group 1 or 3 Woman’s experience of birth position of choice Numerator: Women who reported that a health worker asked them which birth position they preferred Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of time health worker spent with them Numerator: Women who reported being very satisfied or somewhat satisfied with amount of time health worker spent with them during labour Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Women’s satisfaction with the way health providers communicated with them Numerator: Women who reported being very satisfied or somewhat satisfied with the way health workers communicated with them during labour and birth Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s experience of privacy Numerator: number of women who strongly agreed or agreed that their privacy was respected during examinations and treatments Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Women’s experience of being asked permission Numerator: number of women who said their health worker always asked permission before examinations and treatments Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Woman’s overall experience of care Numerator: number of women who strongly agreed or agreed that they felt satisfied with their  labour and birth experience Denominator: Women in Robson Group 1 or 3 who complete postpartum survey Randomization: The intervention will be implemented in labour wards of four hospitals in India in a stepped-wedge, randomized cluster design. All four hospitals will initially be observed under usual care for two months, with the intervention rolled out sequentially (in random order) over a 12-month period, with a hospital transitioning to the intervention every 2 months. A half-month transition period is included for each hospital to allow for the intervention to be fully adopted. Sample size: In the control group, the CS rate in women in Robson group 1 is estimated at 40%. Four hospitals attending 300 women in Robson Group 1 per step will provide 92% power to detect a reduction to 30% (25% relative reduction) (ICC 0.02). Statistical analysis: The analysis will be by intention-to-treat, with rates and 95% CIs calculated for all outcomes. The primary comparison will be composed by the characteristics of the women enrolled at the control period versus those enrolled at the intervention period. For the primary outcome and secondary outcomes a multilevel logistic regression model will be used to estimate effects.