Clinical Research Directory

The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.

This is a multicenter, 1:1 parallel-group, randomized controlled trial designed to compare the effect of the Enhanced Recovery After Cesarean (ERAS) protocol versus standard perioperative care on mother-infant and father-infant bonding in women undergoing cesarean delivery. The study will initially be conducted as a single-center trial at Istanbul Okan University Hospital. Once adequate site preparation is completed, additional centers will be added to expand the study to a multicenter setting. Primary Outcome: The primary outcome is the total score on the Postpartum Bonding Questionnaire (PBQ) assessed on postpartum day 7, reflecting mother-infant bonding. Secondary Outcomes: Secondary outcomes include: Maternal/Parental Postnatal Attachment Scale (MIBS) score at 2 hours postpartum (mother) PBQ score at 24 hours postpartum (mother) PBQ score at day 4 postpartum (mother) PBQ score at day 7 postpartum (father-infant bonding) Edinburgh Postnatal Depression Scale (EPDS) scores for mothers at 2 hours and 7 days postpartum Time to initiation of breastfeeding Requirement for neonatal intensive care unit (NICU) admission Sample Size: The total multicenter target sample size is n=300, with 150 participants in the ERAS group and 150 in the standard care group. The initial single-center phase at Okan University Hospital will enroll a target of n=100 participants (50 per group). Randomization: Participants will be randomized using a block and stratified randomization approach based on parity (primiparous vs multiparous) and planned type of anesthesia. Blinding (Masking): Due to the nature of the intervention, care providers cannot be blinded to group assignment. However, outcome assessors and data analysts will remain blinded to treatment allocation to minimize bias. Study Timeline and Visits: Participants will be evaluated at multiple time points following cesarean delivery: 2 hours postpartum, 24 hours postpartum, day 4 postpartum, and day 7 postpartum. All primary and secondary outcomes will be collected at the specified time points. Significance and Rationale: The ERAS protocol for cesarean delivery is designed to optimize perioperative care, enhance recovery, and potentially improve early parent-infant bonding. While previous studies have focused on maternal recovery and clinical outcomes, evidence regarding the impact of ERAS on both mother-infant and father-infant bonding remains limited. This trial aims to provide high-quality evidence on whether ERAS implementation can improve early bonding experiences, maternal mental health, breastfeeding initiation, and neonatal outcomes compared with standard perioperative care. The findings may guide future clinical practice and contribute to optimizing family-centered care in cesarean deliveries. Key Features: Multicenter, randomized controlled design Parallel 1:1 allocation Stratified randomization by parity and anesthesia type Blinded outcome assessment and data analysis Multiple postpartum evaluation points Focus on psychosocial and clinical outcomes Expected Contributions: This study will provide comprehensive data on the feasibility and effectiveness of ERAS protocols in cesarean deliveries and their potential benefits for both maternal and paternal bonding with the newborn. The inclusion of both mother-infant and father-infant outcomes, as well as maternal mental health and breastfeeding indicators, ensures a holistic assessment of early family-centered outcomes.

Holistic Care Partner Program Feasibility and Acceptability

The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.