Effect of Placenta Delivery Method on Pain, Bleeding and Comfort

Tarsus University

Status: Not yet enrolling

Conditions: Placenta Abruptio

Treatments: Drug: Uteratonic administration; Other: delivery of the placenta; Other: cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT06413186

Sengul Ulucam

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Delivery of the placenta by mixed method

Experimental group

Description:

In 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.

Treatment:

Other: delivery of the placenta

Drug: Uteratonic administration

Other: cord clamping

Delivery of the placenta by active method

Active Comparator group

Description:

In 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.

Treatment:

Other: delivery of the placenta

Drug: Uteratonic administration

Other: cord clamping