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

NCT ID: NCT06677294

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-04-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

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

Placenta remove

Intervention Type: PROCEDURE

This is an observational study. No intervention was performed

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

Placenta remove

Intervention Type: PROCEDURE

This is an observational study. No intervention was performed

Interventions

Placenta remove

This is an observational study. No intervention was performed

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Deniz Akyıldız

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kahramanmaras Sutcu Imam University

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Placenta Removal Interventions

Identifier Type: -

Identifier Source: org_study_id