Placenta AbruptioNCT06413186
Effect of Placenta Delivery Method on Pain, Bleeding and Comfort
A study testing Uteratonic administration, cord clamping and delivery of the placenta in people with Placenta Abruptio, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Abruptio
- What is being tested?
- Uteratonic administration, cord clamping and delivery of the placenta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of Placenta Delivery Method on Postpartum Pain, Bleeding and Comfort of Women: Randomized Controlled Study
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.
Read more
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
- Being tested
- Uteratonic administration, cord clamping, delivery of the placenta
- Keywords
- placenta, labor pain, birt comfort, third stage of labor
- Medical subject headings
- Abruptio Placentae, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uteratonic administrationDrug
Also called Oxytocin administration
Administer IV 10 IU oxytocin
cord clampingOther
delayed cord clamping
delivery of the placentaOther
Applying controlled core traction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Uteratonic administration; Other: cord clamping; Other: delivery of the placenta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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.
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start6 May 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Placenta AbruptioStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Uluçam, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413186
- Sponsor's protocol ID
- Sengul Ulucam
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22015217Begley 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 30754073Dixon 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 22188999Herman 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 11896951Hofmeyr 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 25631379Munoz 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 30865585Prendiville 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 10908457Winter 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 17567419Gulmezoglu 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 19154621Gunaydin B. Management of Postpartum Haemorrhage. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):396-402. doi: 10.5152/TJAR.2022.21438.
PubMed 36511487Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
PubMed 26526404Lowe 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 12011870McDonald 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 23843134Rabe 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Placenta Delivery Method on Postpartum Pain, Bleeding and Comfort of Women: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06413186
- Acronym / sponsor ID
- Sengul Ulucam
- Conditions
- Placenta Abruptio
- Keywords
- placenta, labor pain, birt comfort, third stage of labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Delivery of the placenta by mixed method | Experimental | Drug: Uteratonic administration, Other: cord clamping, Other: delivery 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 method | Active comparator | Drug: Uteratonic administration, Other: cord clamping, Other: delivery 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uteratonic administrationAlso: Oxytocin administrationAdminister IV 10 IU oxytocin | Drug | Delivery of the placenta by active method, Delivery of the placenta by mixed method |
| cord clampingdelayed cord clamping | Other | Delivery of the placenta by active method, Delivery of the placenta by mixed method |
| delivery of the placentaApplying controlled core traction | Other | Delivery of the placenta by active method, Delivery of the placenta by mixed method |
Primary outcome
Visual Analog Skala (VAS)
Time frame: 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"
1 secondary outcome
Postpartum Comfort Scale
Time frame: 15-30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 22015217Begley 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.
- Background: PubMed 30754073Begley 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.
- Background: PubMed 22188999Dixon 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.
- Background: PubMed 11896951Herman 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.
- Background: PubMed 25631379Hofmeyr 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.
- Background: PubMed 30865585Munoz 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.
- Background: PubMed 10908457Prendiville 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.
- Background: PubMed 17567419Winter 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.
- Background: PubMed 19154621Gulmezoglu 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.
- Background: PubMed 36511487Gunaydin B. Management of Postpartum Haemorrhage. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):396-402. doi: 10.5152/TJAR.2022.21438.
- Background: PubMed 26526404Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
- Background: PubMed 12011870Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- 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.385553Link provided by the sponsor.
- Ekşi Z. (2019). Doğum Sonu Dönem. Hemşirelik ve Ebelik İçin Kadın Sağlığı ve Hastalıkları, Bölüm 12, Arslan Ö.E. (editör), Akademisyen Kitabevi, Ankara.Link provided by the sponsor.
- Erdemir F, Çırlak A. (2013). Rahatlık kavramı ve hemşirelik kullanımı. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 6(4), 224-230.Link provided by the sponsor.
- Güngör İ, Yıldırım-Rathfisch G. (2009). Normal doğum eyleminin ikinci ve üçüncü evresinde kanıta dayalı uygulamalar. Hemşirelikte Araştırma Geliştirme Dergisi, 2:56-65.Link provided by the sponsor.
- Karakaplan S, Yıldız H.( 2010). Doğum sonu konfor ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1), 55-65.Link provided by the sponsor.
- Kolcaba K. (2003). Comfort theory and practice: a vision for holistic health care and research. Springer Publishing Co, New YorkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uteratonic administration, cord clamping and delivery of the placenta in people with Placenta Abruptio, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şengül Uluçam (+905531600361, 220931001@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Skala (VAS) (time frame: 15-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413186, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.