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

NCT04965779 | Unknown

• 1 other identifier: CukurovaUniversity_PK_01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

Cesarean Section; Pain; Bleeding; Breast Feeding; Abdominal binder; Nursing postpartum care

Outcome Measures

Primary Outcomes (1)

• Postpartum pain evaluation for cesarean section incision

  Postpartum pain level evaluation for cesarean section incision in this study is determined using Visual Analog Scale \[VAS\]. VAS is a self-report tool used in the subjective assessment of pain. It is in the form of a 10 cm (100 mm) ruler with no pain at one end (minimum pain score=0) and the most severe pain at the other end (maximum pain score=10). The patients indicate the level of pain they perceive by pointing in accordance with their situation. The numerical data of the pain level of the individual is obtained by measuring the distance from the tip where there is no pain to the specified point with a ruler. The score is increased pain level increases. In the study conducted to ensure the standardization of the VAS, it is reported that the vertical use is better understood by the patients. The VAS has been used in many studies evaluating postoperative cesarean delivery pain. In this study, women's VAS scores were evaluated with a vertical form.

  Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours

Secondary Outcomes (4)

• Postpartum pain evaluation for abdomen

  Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours

• Puerperal bleeding amount measurement

  Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours

• Postpartum hemoglobin level and hematocrit ratio

  Up to postpartum 24th hours

• Breastfeeding success evaluation

  Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours

Study Arms (2)

Intervention group (Abdominal binder)

EXPERIMENTAL

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.

Device: Abdominal Binder; Other: Postpartum nursing care

Control group (No abdominal binder)

ACTIVE COMPARATOR

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.

Other: Postpartum nursing care

Interventions

Abdominal Binder 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.

Intervention group (Abdominal binder)

Postpartum nursing care 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); Intervention group (Abdominal binder)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Gender Eligibility Details: At the ≥38th gestational week
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Central, 51200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39780504 DERIVED

MeSH Terms

Conditions

Pain; Hemorrhage; Breast Feeding

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Feeding Behavior; Behavior

Study Officials

• Pınar Kara, MSc

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

• Evşen Nazik, PhD

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 16, 2021
• Study Start: September 22, 2020
• Primary Completion: March 19, 2021
• Study Completion: December 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 year
• Access Criteria: The published protocol can be used to set an example for scientific research planning. The principal investigator can be contacted to provide data source for meta-analysis and systematic review studies.

Locations

TU (1)