Effect of Placenta Delivery Method on Pain, Bleeding and Comfort

NCT06413186 | Not Yet Recruiting

• 1 other identifier: Sengul Ulucam
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Abruptio

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Skala (VAS)

  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"

  15-30 minutes

Secondary Outcomes (1)

• Postpartum Comfort Scale

  15-30 minutes

Study Arms (2)

Delivery of the placenta by mixed method

EXPERIMENTAL

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.

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

Delivery of the placenta by active method

ACTIVE COMPARATOR

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.

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

Interventions

Uteratonic administration DRUG

Administer IV 10 IU oxytocin

Also known as: Oxytocin administration

Delivery of the placenta by active method; Delivery of the placenta by mixed method

cord clamping OTHER

delayed cord clamping

Delivery of the placenta by active method; Delivery of the placenta by mixed method

delivery of the placenta OTHER

Applying controlled core traction

Delivery of the placenta by active method; Delivery of the placenta by mixed method

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agreeing to participate in the research
• No communication problems
• Between 19-35 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus üniversitesi

Mersin, Tarsus, 33400, Turkey (Türkiye)

Location

Related Publications (14)

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• Gulmezoglu AM, Widmer M, Merialdi M, Qureshi Z, Piaggio G, Elbourne D, Abdel-Aleem H, Carroli G, Hofmeyr GJ, Lumbiganon P, Derman R, Okong P, Goudar S, Festin M, Althabe F, Armbruster D. Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial. Reprod Health. 2009 Jan 21;6:2. doi: 10.1186/1742-4755-6-2.

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• Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.

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• Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.

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• McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.

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• Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003248. doi: 10.1002/14651858.CD003248.pub3.

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Related Links

• Durmaz A, Kömürcü N. (2018). Postpartum Kanamada Risk Belirleme, Önleme ve Yönetim: Kanıta Dayalı Uygulamalar. Sağlık Bilimleri ve Meslekleri Dergisi, 5(3), 494-502.https:// doi.org/10.17681/hsp.385553
• Ekşi Z. (2019). Doğum Sonu Dönem. Hemşirelik ve Ebelik İçin Kadın Sağlığı ve Hastalıkları, Bölüm 12, Arslan Ö.E. (editör), Akademisyen Kitabevi, Ankara.
• Erdemir F, Çırlak A. (2013). Rahatlık kavramı ve hemşirelik kullanımı. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 6(4), 224-230.
• FIGO/ICM Joint Statement. Management of the Third Stage of Labour to Prevent Post-partum Haemorrhage. 2007.
• Güngör İ, Yıldırım-Rathfisch G. (2009). Normal doğum eyleminin ikinci ve üçüncü evresinde kanıta dayalı uygulamalar. Hemşirelikte Araştırma Geliştirme Dergisi, 2:56-65.
• Karakaplan S, Yıldız H.( 2010). Doğum sonu konfor ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1), 55-65.
• Kolcaba K. (2003). Comfort theory and practice: a vision for holistic health care and research. Springer Publishing Co, New York
• Kuğuoğlu S, Karabacak Ü. (2008). Genel konfor primipar ve multipar gebelerde doğum ve doğum sonu döneme ilişkin endişelerin ölçeğinin Türkçe' ye uyarlanması. İstanbul Üniversitesi Florence Nightingale Hemşirelik Dergisi, 16(61), 16-23.
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MeSH Terms

Conditions

Abruptio Placentae; Labor Pain

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Şengül Uluçam

CONTACT

+905531600361; 220931001@tarsus.edu.tr

Gülüzar Sade

CONTACT

+905467339555; guluzarsade@tarsus.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: midwife, Student on master degree program at Tarsus University Midwife

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 14, 2024
• Study Start: May 6, 2024
• Primary Completion: September 20, 2024
• Study Completion: March 20, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)