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

**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.