The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women

NCT ID: NCT04965779

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2022-12-31

Brief Summary

The aim of this randomized controlled interventional study is to identify the effect of the use of an abdominal binder on postpartum pain, bleeding, and breastfeeding success in primiparous women who have undergone planned cesarean delivery with spinal anesthesia.

Detailed Description

A 2015 report by the World Health Organization (WHO) has emphasized that cesarean section can be effective in preventing maternal and perinatal mortality and morbidity when there is a life-threatening danger to the mother and/or fetus, but provides no benefit to the woman or the baby otherwise. It also states that the ideal cesarean section rate 10% to 15%, and a rate above 10% at the population level is ineffective in decreasing maternal and infant mortality. However, current cesarean rates are much higher than recommended, especially in developed western countries, and rates ranging from 14.8% (Israel) to 54.8% (Turkey) have been reported as of 2018. Turkey, with a rate of 54.8%, has the highest cesarean section rate among the reported data.

Cesarean delivery is common worldwide and presents many maternal and neonatal risks. While bleeding is the most serious of these risks, the women also experience severe pain and face problems with breastfeeding. The risk of a postpartum bleeding complication is reported to be 2.5 times higher in women who have undergone a planned cesarean section. The rate of experiencing any pain after a cesarean section has been reported as 77% to 92.7% while the incidence of moderate/severe pain is 15.2% to 52.2%. In addition, the probability of experiencing breastfeeding problems in the post-cesarean period is reported to be approximately 7 times higher.

The need for optimum care in the postpartum period in order to protect the health of both the mother and the newborn, and also to prevent the health problems that may develop in the short and long term has been emphasized. Appropriate interventions of the nurses who are in close contact with the women, the newborns, and the families during the postpartum period affect the quality of care significantly. Based on this information, the various effects of the post-cesarean use of an abdominal binder, which is a noninvasive nursing intervention, has been evaluated in the literature and shown to have various benefits in the management of postpartum complications and problems after cesarean section in women with various characteristics. A limited number of studies have reported that the use of an abdominal binder decreases pain but inconsistent effect on postpartum bleeding. However, there is no study evaluating the effect of abdominal binder use on breastfeeding success.

The study was planned as a randomized controlled interventional study with the women randomly divided into intervention (abdominal binder) and control groups. A preliminary application was used to determine the sample size of the study. Based on the power analysis performed with the data obtained, a total of 128 women were included in the study with 64 women in each group, at a confidence interval of 95%, power of 90%, and α level of 0.05.

Block random sampling method was adopted to recruit participants. In order to randomly assign the participants to the groups, a list of 1:1 random numbers was created with the software Research Randomizer (https://www.randomizer.org/) on the computer. Participants were assigned to groups by 8-block randomization method. Randomization was done by an expert statistical consultant who was not responsible for conducting the study. The determined randomization number of list was printed out separately and sealed in each envelope. The random number was hidden in sealed envelopes until participants approved to participate in the study. Writing the random numbers on the papers, placing them in the envelopes and opening the paper in the sealed envelopes were done by an independent volunteer who was not responsible for the conduct of the study. Those who meet the inclusion and exclusion criteria and approve to participate in the study was allocated to intervention (abdominal binder) group or control group according to the result of randomization. In order to prevent bias each participant in the groups was followed in different rooms from the other participants in the group to which they were assigned.

SPSS software (IBM Corp., Armonk, NY, v. 24.0) will be used to evaluate the data. Descriptive analysis will be calculated using mean and standard deviation, median and interquartile range for continuous variables, and percentage and frequency for categorical variables. Independent sample t-tests, Mann-Whitney U test, chi-square test or Fisher's exact test will be used to compare any differences in socio-demographic data or outcome variables between groups. To determine the differences or changes between study group and control group (between group effects), within group effects (time), and the interaction effects (group x time), repeated measures analysis of variances (RM-ANOVA) and to compare the variables with two repeated measurements paired sample t-test will be applied when assumptions for parametric test are fulfilled. When the data cannot fulfill the assumptions of parametric test, Mann-Whitney U test will be applied to compare the differences between groups at each time interval while Friedman test will be used to determine the time effects within each group. Significant results are indicated if p-value of all statistical analysis is less than 0.05 for two-tailed test.

Tools for measuring the outcome variables in this study have been demonstrated validity and reliability (Breastfeeding Assesment Scale [LATCH]) and selectivity (Visual Analog Scale [VAS]) in Turkey.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group (Abdominal binder)

The abdominal binder is applied after the women come to the clinic (postpartum 1st hour) following cesarean delivery and removed after the postpartum 48th hour. Postpartum nursing care in line with a follow-up protocol that was created based on the Republic of Turkey Ministry of Health's Postpartum Care Management Guide (2018) is provided together with the application of the abdominal binder.

Group Type: EXPERIMENTAL

Abdominal Binder

Intervention Type: DEVICE

Women in the intervention group use an abdominal binder from postpartum hour 1 to 48, and will be checked every 6 hours. The abdominal circumference of the women is measured at the anterior superior iliac spine and umbilicus level with a tape measure before the application, and the binder size is adjusted to be 5% smaller (approximately 0.5-1 cm) than the measurement obtained.

Postpartum nursing care

Intervention Type: OTHER

Postpartum nursing care the follow-up protocol includes the evaluation and record between postpartum 1. and 48. hours of pain level, analgesic administration, follow-up of the puerperal bleeding, and uterine tone, measure of hemodynamic parameters measuring, hemoglobin level and hematocrit ratio, and assessment breastfeeding.

Control group (No abdominal binder)

Only postpartum nursing care in line with a follow-up protocol that was created based on the Republic of Turkey Ministry of Health's Postpartum Care Management Guide (2018) is provided with no abdominal binder or similar application.

Group Type: ACTIVE_COMPARATOR

Postpartum nursing care

Intervention Type: OTHER

Postpartum nursing care the follow-up protocol includes the evaluation and record between postpartum 1. and 48. hours of pain level, analgesic administration, follow-up of the puerperal bleeding, and uterine tone, measure of hemodynamic parameters measuring, hemoglobin level and hematocrit ratio, and assessment breastfeeding.

Interventions

Abdominal Binder

Women in the intervention group use an abdominal binder from postpartum hour 1 to 48, and will be checked every 6 hours. The abdominal circumference of the women is measured at the anterior superior iliac spine and umbilicus level with a tape measure before the application, and the binder size is adjusted to be 5% smaller (approximately 0.5-1 cm) than the measurement obtained.

Intervention Type: DEVICE

Postpartum nursing care

Postpartum nursing care the follow-up protocol includes the evaluation and record between postpartum 1. and 48. hours of pain level, analgesic administration, follow-up of the puerperal bleeding, and uterine tone, measure of hemodynamic parameters measuring, hemoglobin level and hematocrit ratio, and assessment breastfeeding.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Can read and write in Turkish,
• Conscious and cooperating,
• Aged ≥19 to <35 years,
• At the ≥38th gestational week,
• Primiparous,
• With a healthy, singleton pregnancy and fetus,
• Scheduled to undergo cesarean delivery under spinal anesthesia and then undergoes the procedure,
• A minimum blood hemoglobin level of ≥11 g/dl and minimum hematocrit ratio of ≥36% at the time of cesarean delivery,
• Has the infant with her from cesarean delivery until discharge

Exclusion Criteria

• A maternal systemic disease,
• A chronic pain problem or regular use of pain medications,
• A psychiatric disease,
• Scheduled to undergo or has undergone any intervention or drug administration in the pre-/intra-/post-operative period,
• Development of any complication in the pre-/intra-/post-operative period,
• Drain placement in the postpartum period

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Kara Pınar

Research Asisstant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pınar Kara, MSc

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Evşen Nazik, PhD

Role: STUDY_DIRECTOR

Cukurova University

Locations

Nigde Omer Halisdemir University

Niğde, Central, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kara P, Nazik E. The effect of an abdominal binder on pain, bleeding and breastfeeding success after cesarean delivery: A randomized controlled trial. Women Health. 2025 Feb;65(2):124-139. doi: 10.1080/03630242.2024.2448514. Epub 2025 Jan 8.

Reference Type: DERIVED

PMID: 39780504 (View on PubMed)

Other Identifiers

CukurovaUniversity_PK_01

Identifier Type: -

Identifier Source: org_study_id