Skip to content

Effect of Placenta Delivery Method on Pain, Bleeding and Comfort

Examining the Effect of Placenta Delivery Method on Postpartum Pain, Bleeding and Comfort of Women: Randomized Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06413186
Enrollment
140
Registered
2024-05-14
Start date
2024-05-06
Completion date
2025-03-20
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Abruptio

Keywords

placenta, labor pain, birt comfort, third stage of labor

Brief summary

The aim of this thesis is to examine the effect of the placenta delivery method on women's postpartum pain, bleeding and comfort. It is a randomized controlled experimental study. The research will be conducted at Mersin Tarsus state hospital between March 2024 and August 2024. The study will be conducted with 140 primiparous women, 70 primiparous pregnant women in the experimental group and 70 primiparous pregnant women in the control group, who meet the research criteria and apply to the delivery room of Tarsus State Hospital between these dates. The research will be carried out with a control group (those receiving routine hospital protocol/where the placenta is delivered with controlled cord traction) and an experimental group (physiological separation of the placenta with a mixed method). Interventions applied to research groups vary depending on the characteristics of the group. In both groups, interventions in the delivery room will be performed by the researcher midwife. If any complications develop during the research, independent of the interventions, if the woman undergoes a cesarean section, or if situations that meet the exclusion criteria occur, that woman will be excluded from the sample. The researcher will apply a routine hospital birth management protocol to both groups during the first three stages of labor. However, the way the placenta is delivered in the third stage (physiological with mixed management or controlled cord traction with active management) will differ. The researcher will apply the Visual Analogue Scale (VAS) twice, at the beginning and at the end of the third phase of labor, apply the Postpartum Comfort Scale at the 4th postpartum hour, and record hemoglobin and hematocrit values at admission to the hospital, which is the hospital's routine protocol, and in the hemogram test at the 6th hour postpartum. HB and HCT values will be used to interpret the amount of postpartum bleeding. The hypotheses of the research are as follows; H1: In the active management of the 3rd stage of labor, delivery of the placenta with controlled cord traction affects the woman's perception of postpartum pain. H2: In the active management of the 3rd stage of labor, delivering the placenta with controlled cord traction affects the woman's amount of postpartum bleeding. H3: In the active management of the 3rd stage of labor, delivering the placenta with controlled cord traction affects the woman's postpartum comfort level. H4: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the woman's perception of postpartum pain. H5: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the amount of postpartum bleeding of the woman. H6: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the woman's postpartum comfort level.

Interventions

DRUGUteratonic administration

Administer IV 10 IU oxytocin

delayed cord clamping

OTHERdelivery of the placenta

Applying controlled core traction

Sponsors

Tarsus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

This study is a parallel group, randomized controlled study conducted at the public hospital in Tarsus district of Mersin province. It will consist of primiparas (women who will give birth for the first time) who apply to the delivery room of Tarsus State Hospital. The sample of the research was calculated with the G-Power program. The sample size was calculated as 64 primiparous and 128 primiparous in each group. in total. However, assuming that there will be at least 10% data loss during the research, the study will be carried out with a total of 140 primiparas, 70 primiparas in each group. 70 primiparas who meet the inclusion criteria for the study will be assigned to the experimental group (physiological separation of the placenta using a mixed method), and 70 primiparas will be assigned to the control group (controlled cord traction will be used to deliver the placenta). ) through randomization.

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

Agreeing to participate in the research * No communication problems * Between 19-35 years old * 38-42 weeks of gestation * Having a single and healthy fetus and newborn * Having a vaginal birth * Firstborn * Women who are not at risk during birth and postpartum period

Exclusion criteria

Women who develop complications during birth and the postpartum period (placenta not separating, part of the placenta remaining in the uterus, development of atony, manual rupture of the uterus, cord rupture, etc.) * Those receiving anticoagulant treatment during pregnancy * The duration of the 3rd stage of labor lasts more than 30 minutes * Instrumental (using vacuum/forceps) birth

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Skala (VAS)15-30 minutesIt is a scale in which the person marks the part expressing his/her pain on a 10 cm ruler where painlessness and unbearable pain are shown at each end. VAS was preferred because it is easy to use, sensitive in measuring pain intensity, and reliable. In the evaluation of VAS, 0-2 cm indicates no pain, 3-4 cm indicates mild pain, 5-6 cm indicates Moderate pain, 7-8 cm indicates Severe pain and 9-10 cm indicates Unbearable. shows pain

Secondary

MeasureTime frameDescription
Postpartum Comfort Scale15-30 minutesIt was developed by Karakaplan and Yıldız in 2010 to measure the physical, psychospiritual and sociocultural comfort of women giving birth. The scale has a 5-point Likert structure (totally agree: 5 points and strongly disagree: 1 point) and consists of a total of 34 items. Totally agree in the positive items in the scale indicates high comfort (5 points), while negative items indicate low comfort (1 point). score). As the scores obtained from the scale increase, it shows that the comfort level increases. As a result of the study, scores close to 170 indicate that the person's comfort is high.

Countries

Turkey (Türkiye)

Contacts

Primary ContactŞengül Uluçam
220931001@tarsus.edu.tr+905531600361
Backup ContactGülüzar Sade
guluzarsade@tarsus.edu.tr+905467339555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026