NCT07196202

Brief Summary

The goal of this clinical trial is to evaluate the effect of laid back breast feeding position on breastfeeding experience among multiparous women. The main questions it aims to answer are;

  • Do postpartum women who feed their babies in a laid-back position report a better breastfeeding experience than those who use the cradle position?
  • Do postpartum women who feed their babies in a laid-back position report greater breastfeeding comfort than those who use the cradle position? Researchers will compare breastfeeding in laid-back position to cradle position to see if postpartum women who feed their babies in a laid-back position have better breastfeeding experience and comfort Participants will:
  • Have educational sessions on breastfeeding in laid-back position during antenatal visit of the 3rd trimester
  • Will be followed by the researcher for any clarifications about the educational content of session
  • Will be asked to apply laid-back position after giving birth, so, the researcher evaluate its effect on breastfeeding experience and comfort.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 19, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

laid back positionbreastfeeding experiencebreastfeeding comfort

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Experience Scale (BES)

    BES consists of 30 items (18- items to assess presence or absence and severity of common breastfeeding difficulties in the early postpartum period and 12 items to assess breastfeeding continuation and the reasons for weaning). In the current study, the researcher used the 18 item part of BES because it suites the aim of the study. The 18-item part are divided into five categories including 3items for breast concern, 5 items for mechanics of breast concern, 5 items for process concern, 3 items for insufficient milk production and 2 items for social concern. Scoring system The score system for breastfeeding difficulties using three point Likert scale ranged from "never" (1), "sometimes" (2) and "always" (3). The total scores were ranged from 18 to 54. the level of difficulties were categorized as the following: low severity (\< 60%) were ranged from 0 \> 32point, average severity (60 % to \< 80%) were ranged from 32 \> 43 point and high severity (≥80 %) were ranged from 43≥ 54 point.

    1st time for assessment will be within 24 to 48 hrs after giving birth. 2nd time for assessment will be one week after birth.

Secondary Outcomes (1)

  • Maternal comfort during breastfeeding (MCRS)

    One week after delivery

Study Arms (2)

Laid-Back Positioning Group

ACTIVE COMPARATOR

Multiparous women who receive structured training and support on the laid-back breastfeeding position during the last trimester of pregnancy so, they can apply it after giving birth

Other: Laid-Back position training

Standard Care Group

PLACEBO COMPARATOR

Multiparous women who receive the standard postpartum breastfeeding care and support offered by the hospital after giving birth

Other: Standard Postpartum Care

Interventions

This intervention is a structured training session for pregnant woman on the use of the laid-back breastfeeding position after birth. The training is designed to be delivered in a single, standardized session by the researcher during the last trimester of pregnancy to be applied within the first 24 hours post-cesarean delivery.

Laid-Back Positioning Group

Postpartum mothers who receive structured training and support on the laid-back breastfeeding position

Standard Care Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Multiparous women aged 20 -35 years.
  • Multiparous women At the 34 to 36 weeks of gestational age
  • Multiparous women with normal course of pregnancy with single-tone fetus
  • Multiparous women planning to deliver at Mansoura University Hospital
  • Multiparous women who will perform elective caesarian section
  • Multiparous women planning to breast feed their babies
  • Multiparous women who have no information about laid breastfeeding position
  • Multiparous women who will deliver neonate with normal ABGAR score
  • Multiparous women who will deliver neonate weight 2.5: 3.5 kg.

You may not qualify if:

  • Mothers who had inverted or flat nipple.
  • Mothers who have postpartum complications
  • Mothers who delivered babies with cleft lip, cleft palate, preterm, neurological deficit, asphyxia or any abnormal condition will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

New Obstetric and Gynecological Center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

  • Nadia Y AbdElla, Asistatnt Professor

    Faculty of Nursing- Mansoura University- Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Y AbdElla, Assisttant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One group of mothers (the intervention group) will be trained on the laid-back position. The other group (the control group) will receive standard care. The outcomes for these two distinct groups were then compared. The groups will treated independently and in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 29, 2025

Study Start

December 1, 2025

Primary Completion

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The reason for not sharing data is to comply with and protect the confidentiality of participants, which is a primary ethical requirement in research.

Locations