CClinicalTrials.gg
Not yet recruitingNCT06413186Updated May 14, 2024

Effect of Placenta Delivery Method on Pain, Bleeding and Comfort

An interventional study of Uteratonic administration and cord clamping in Placenta Abruptio, sponsored by Tarsus University. Not yet recruiting at 1 site in Turkey. Open to female participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Tarsus University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
19 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta Abruptio

Browse trials for

Keywords

  • placenta
  • labor pain
  • birt comfort
  • third stage of labor
03

Who can participate

Ages eligible
19 Years to 35 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Delivery of the placenta by mixed method

    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

  • Active comparator
    Delivery of the placenta by active method

    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

  • DrugUteratonic administration

    Administer IV 10 IU oxytocin

    Also known as: Oxytocin administration

  • Othercord clamping

    delayed cord clamping

  • Otherdelivery of the placenta

    Applying controlled core traction

05

What researchers measure

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"

    Time frame: 15-30 minutes

Secondary outcomes

  1. Postpartum Comfort Scale

    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.

    Time frame: 15-30 minutes

06

Study locations

1 site
  • Tarsus üniversitesi
    Mersin, Tarsus 33400, Turkey
07

References and documents

Publications

  • Begley CM, Guilliland K, Dixon L, Reilly M, Keegan C. Irish and New Zealand midwives' expertise in expectant management of the third stage of labour: the 'MEET' study. Midwifery. 2012 Dec;28(6):733-9. doi: 10.1016/j.midw.2011.08.008. Epub 2011 Oct 19. PubMed 22015217 ↗
  • Begley CM, Gyte GM, Devane D, McGuire W, Weeks A, Biesty LM. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD007412. doi: 10.1002/14651858.CD007412.pub5. PubMed 30754073 ↗
  • Dixon L, Tracy SK, Guilliland K, Fletcher L, Hendry C, Pairman S. Outcomes of physiological and active third stage labour care amongst women in New Zealand. Midwifery. 2013 Jan;29(1):67-74. doi: 10.1016/j.midw.2011.11.003. Epub 2011 Dec 20. PubMed 22188999 ↗
  • Herman A, Zimerman A, Arieli S, Tovbin Y, Bezer M, Bukovsky I, Panski M. Down-up sequential separation of the placenta. Ultrasound Obstet Gynecol. 2002 Mar;19(3):278-81. doi: 10.1046/j.1469-0705.2002.00557.x. PubMed 11896951 ↗
  • Hofmeyr GJ, Mshweshwe NT, Gulmezoglu AM. Controlled cord traction for the third stage of labour. Cochrane Database Syst Rev. 2015 Jan 29;1(1):CD008020. doi: 10.1002/14651858.CD008020.pub2. PubMed 25631379 ↗
  • Munoz M, Stensballe J, Ducloy-Bouthors AS, Bonnet MP, De Robertis E, Fornet I, Goffinet F, Hofer S, Holzgreve W, Manrique S, Nizard J, Christory F, Samama CM, Hardy JF. Patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage. A NATA consensus statement. Blood Transfus. 2019 Mar;17(2):112-136. doi: 10.2450/2019.0245-18. Epub 2019 Feb 6. PubMed 30865585 ↗
  • Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev. 2000;(3):CD000007. doi: 10.1002/14651858.CD000007. PubMed 10908457 ↗
  • Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x. PubMed 17567419 ↗
  • 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. PubMed 19154621 ↗
  • Gunaydin B. Management of Postpartum Haemorrhage. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):396-402. doi: 10.5152/TJAR.2022.21438. PubMed 36511487 ↗
  • Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205. PubMed 26526404 ↗
  • 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. PubMed 12011870 ↗
  • 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. PubMed 23843134 ↗
  • 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. PubMed 22895933 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06413186
Lead sponsor
Tarsus University
Responsible party
Şengül Uluçam (midwife, Student on master degree program at Tarsus University Midwife, Tarsus University) — Principal investigator
First posted
May 14, 2024
Start date
May 6, 2024 (estimated)
Primary completion
Sep 20, 2024 (estimated)
Completion
Mar 20, 2025 (estimated)
Last update
May 14, 2024

Study contacts

Şengül Uluçam
Contact
220931001@tarsus.edu.tr
+905531600361
Gülüzar Sade
Contact
guluzarsade@tarsus.edu.tr
+905467339555

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion