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Effect of Placenta Delivery Method on Pain, Bleeding and Comfort

Not Applicable
Not yet recruiting
Conditions
Placenta Abruptio
Interventions
Drug: Uteratonic administration
Other: cord clamping
Other: delivery of the placenta
Registration Number
NCT06413186
Lead Sponsor
Tarsus University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
140
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Delivery of the placenta by mixed methodUteratonic administrationIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be delivered physiologically.
Delivery of the placenta by mixed methodcord clampingIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be delivered physiologically.
Delivery of the placenta by mixed methoddelivery of the placentaIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be delivered physiologically.
Delivery of the placenta by active methodUteratonic administrationIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be removed with controlled cord traction.
Delivery of the placenta by active methodcord clampingIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be removed with controlled cord traction.
Delivery of the placenta by active methoddelivery of the placentaIn this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be removed with controlled cord traction.
Primary Outcome Measures
NameTimeMethod
Visual Analog Skala (VAS)15-30 minutes

It 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 Outcome Measures
NameTimeMethod
Postpartum Comfort Scale15-30 minutes

It 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.

Trial Locations

Locations (1)

Tarsus üniversitesi

🇹🇷

Mersin, Tarsus, Turkey

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