The Effects of Intrauterine Interventions During Placenta Removal on Pain, Perception of Traumatic Birth, and Early Postpartum Health Indicators in Women

NCT06677294 | Completed

• 1 other identifier: Placenta Removal Interventions
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study was conducted with 64 women who had vaginal deliveries at Adana City Training and Research Hospital between October 2023 and May 2024. Women who received intrauterine interventions during the third stage of labor formed the case group (n=32), and those who did not formed the control group (n=32). Data were collected using the Pregnant Information Form, Labor Observation Form, Early Postpartum Period Follow-up Form, Visual Analog Scale (VAS), and Traumatic Birth Perception Scale (TBPS). Findings were determined through regular monitoring and follow-ups during the first 24 hours postpartum.

Conditions

Placenta, Retained

Outcome Measures

Primary Outcomes (3)

• Women's pain levels

  The Visual Analog Scale (VAS) was used to assess pain levels in this study. The VAS is a continuous scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores on the VAS indicate a worse outcome, as they reflect greater levels of reported pain.

  VAS scores were recorded at 10 minutes, 30 minutes, 1 hour, 12 hours, and 24 hours postpartum

• Traumatic Birth Perception

  The Traumatic Birth Perception Scale (TBPS) was developed to measure the perception of traumatic birth in women and consists of 13 items within a single subdimension. There are no reverse-scored items in the scale, and each item is rated on a scale of 0 to 10. The lowest possible score is 0, and the highest possible score is 130. The total score reflects the level of traumatic birth perception, with higher scores indicating a higher perception of trauma related to the birth experience.

  At 24 hours postpartum

• Early postpartum health characteristics

  10th minute, 15th minute, 20th minute, 30th minute, 45th minute, 60th minute, 90th minute, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 12th hour, 18th hour and 24th hour

Study Arms (2)

Control

while those who did not undergo such interventions were placed in the control group

Procedure: Placenta remove

Case

In the study, women who underwent intrauterine interventions during the third stage of labor for placental removal were included in the case group (n=32), while those who did not undergo such interventions were placed in the control group (n=32). Manual placental removal (hallas) and the cleaning of the uterine cavity using the hand or gauze/sponge (wrapped around the hand or using an over-clamp) after placental expulsion were considered intrauterine interventions

Procedure: Placenta remove

Interventions

Placenta remove PROCEDURE

This is an observational study. No intervention was performed

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Placenta, Retained

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: November 6, 2024
• Study Start: September 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: April 15, 2024
• Last Updated: November 6, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)