Clinical trial NCT06413186: Effect of Placenta Delivery Method on Pain, Bleeding and Comfort
Official title: Examining the Effect of Placenta Delivery Method on Postpartum Pain, Bleeding and Comfort of Women: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Placenta Abruptio
Keywords: placenta
labor pain
birt comfort
third stage of labor
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 140
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Skala (VAS)
timeFrame: 15-30 minutes
Secondary outcomes:
measure: Postpartum Comfort Scale
timeFrame: 15-30 minutes
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus üniversitesi
state: Tarsus
Study officials:
References:
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