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OpenTrials
Completed

NCT Number: NCT06677294

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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. Additionally, participants must not have been using analgesic medications, must not have had hypertension or preeclampsia, and must not have experienced atony in a previous pregnancy. Participants also needed to be free from infections, placental anomalies, genital lesions, or coagulation disorders, and they had to agree to participate in the study

Exclusion criteria

Exclusion criteria

included women who experienced a difficult labor or whose delivery involved the use of forceps or vacuum assistance.

Treatment and study plan

Placenta remove

Procedure

This is an observational study. No intervention was performed

Primary outcomes

  1. Women's pain levels

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

    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.

  2. Traumatic Birth Perception

    Time frame: At 24 hours postpartum

    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.

  3. Early postpartum health characteristics

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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