Clinical trial NCT04965779: The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women
Official title: The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Women Who Undergo Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean Section
Pain
Bleeding
Breast Feeding
Abdominal binder
Nursing postpartum care
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 128
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postpartum pain evaluation for cesarean section incision
timeFrame: Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours
Secondary outcomes:
measure: Postpartum pain evaluation for abdomen
timeFrame: Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours
measure: Puerperal bleeding amount measurement
timeFrame: Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours
measure: Postpartum hemoglobin level and hematocrit ratio
timeFrame: Up to postpartum 24th hours
measure: Breastfeeding success evaluation
timeFrame: Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Central
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Pınar Kara, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University
name: Evşen Nazik, PhD
role: STUDY_DIRECTOR
References: