Vogel, Joshua P.
Pingray, Veronica
Althabe, Fernando
Gibbons, Luz
Berrueta, Mabel
Pujar, Yeshita
Somannavar, Manjunath
Vernekar, Sunil S.
Ciganda, Alvaro
Rodriguez, Rocio
Welling, Saraswati A.
Revankar, Amit
Bendigeri, Savitri
Kumar, Jayashree Ashok
Patil, Shruti Bhavi
Karinagannanavar, Aravind
Anteen, Raveendra R.
Pavithra, M. R.
Shetty, Shukla
Latha, B.
Megha, H. M.
Gaddi, Suman S.
Chikkagowdra, Shaila
Raghavendra, Bellara
Armari, Elizabeth
Scott, Nick
Eddy, Katherine
Homer, Caroline S. E.
Goudar, Shivaprasad S.
Article History
Received: 25 April 2022
Accepted: 8 November 2022
First Online: 20 January 2023
Declarations
:
: This project is being conducted in accordance with GCP standards. It has been designed and will be conducted in accordance with the principles set out by the World Medical Association (WMA) in the Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects (2013) and Council for International Organisation of Medical Science (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans (2016). As it is a cluster randomised trial, it will be performed in accordance with the Ottawa Statement for the Ethical Design and Conduct of Cluster Randomised Trials (2012). The trial protocol was reviewed and approved by the Alfred Hospital Human Ethics Committee (737/20), the Institutional Ethics Committee of the KLE Academy of Higher Education and Research, Belagavi, Karnataka, India (KAHER/EC/2020-21/D-281120003); the Institutional Ethics Committee of J J M Medical College, Davanagere, Karnataka (JJMMC/IEC-136/2020); the Institutional Ethics Committee of Vijayanagar Institute of Medical Sciences (VIMS), Ballari, Karnataka (VIMS/STD/SVN IEC/20/2020-2021), the Institutional Ethics Committee, Gadag Institute of Medical Sciences, Gadag, Karnataka (GIMS/IEC/01/2020-21), the State Ethics Committee, Department of Health and Family Welfare, Government of Karnataka (DD(MH)/71/2020-21); and the Health Ministry's Screening Committee, Indian Council of Medical Research (2020-10127) Annual reports on study progress will be provided to these committees.The need to improve provision of good-quality intrapartum care has also been emphasised in the Government of India’s 2017 Labour Room Quality Improvement Initiative (LaQshya) [CitationRef removed] which aims to reduce maternal and newborn morbidity and mortality; improve quality of care during delivery and immediate post-partum period, and enhance satisfaction of beneficiaries, positive birthing experience and provide Respectful Maternity Care (RMC) to all pregnant women attending public health facilities. The LCG strategy aims to change local healthcare providers’ behaviour for management of labour and birth, and increase compliance with WHO recommendations. The LCG is the WHO recommended tool for managing women in labour.<b>Facilities: </b>The clinical leadership at each facility will provide facility-level permission for participation in the study and permission for staff employed at the health facility to extract non-identifiable routinely collected data on clinical outcomes.<b>Providers:</b> Informed consent will be explicitly sought from healthcare providers attending LCG training activities. They will receive an Information Sheet and Consent Form which will be administered by study staff, in a private setting. Providers will be encouraged to ask as many questions as they need to understand the implications of participation. Separate informed consent will be obtained from healthcare providers for data collection related to the process evaluation, including interviews and surveys.<b>All women giving birth:</b> The trial evaluates a complex intervention targeted to healthcare providers providing care during and childbirth. For all women giving birth in participating hospitals during the study period, we will collect a few routine variables (non-identifiable data) on their birth and birth outcomes from medical records and the labour ward registry. They will not be directly approached or interviewed. According to the Ottawa Statement,[CitationRef removed] “simply being a patient or a professional participating in a cluster randomised trial of an educational, knowledge translation, or quality improvement intervention does not make one a research participant” (Ottawa Statement 3). Hence, women having births are not research participants in the study.<b>Postpartum survey of a sample of women:</b> In a subset of women who have given birth, we will obtain informed consent for data collection prior to completion of a postpartum survey on their experiences. The survey will be administered by trained research staff. As these women in the postpartum period, we anticipate that some of these women may be unwell or may have experienced a stillbirth. Women will only be approached for a survey if they were aged 18 and over, had a live birth, if their vital signs are normal, they are not presenting in general state of distress and able to complete a screening and informed consent process. This process which will be conducted in a private setting, where women will be provided with information in their own language of choice and it will be made clear she is free to refuse or withdraw from the survey.<b>Gatekeepers:</b> Gatekeepers are individuals or bodies who may be called upon to protect the group-based interests that are affected by enrolment in a cluster randomised trial. At each study hospital, permission will be obtained from the institutional leadership for the health hospital (eg: Head of Obstetrics and Gynaecology Department) to participate in the trial.
: Not applicable.
: The authors declare that they have no competing interests.