- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275438
Comparison of Oxytocin Receptor Immunoreactivity in Placentas Obtained From Women Having Cesarean and Natural Birth
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Merkez
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Kars, Merkez, Turkey, 36100
- Kafkas Universty
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Mothers with a body mass index within this range:18kg/m2≥Body Mass Index (BMI)≤35kg/m2 Healthy mothers who have had both vaginal and cesarean deliveries Mothers aged over 18 and under 35 years old
Exclusion Criteria:
- Chronic diseases Gynecological disorders Intrauterine growth restriction Placental anomalies Forensic cases of pregnancy Premature births Eclampsia-Preeclampsia Multiple pregnancies Body Mass Index (BMI) ≥35kg/m2 Body Mass Index (BMI) ≤18kg/m2 Experience of trauma during pregnancy Non-cesarean surgical interventions during pregnancy Severe infections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: experimental group
The group consists of mothers who meet the inclusion criteria specified in the study, have an 8cm dilation at term, and undergo cesarean section delivery.
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At Kars Harakani State Hospital and Kafkas University, 16 placentas were collected, with 8 obtained from induced deliveries and 8 from spontaneous deliveries, between 09:00-21:00.
Nulliparity and multiparity were not distinguished among the expectant mothers.
Placentas were obtained hours before delivery from mothers admitted to the gynecology service, whose eligibility was determined based on exclusion criteria, after obtaining signed informed consent forms, with assurances given that no interventional procedures would be performed on the mother or the baby.
The method of cesarean section (spinal or general anesthesia) in the case group was recorded, ensuring that the anesthetic agents used contained the same active ingredients.
Placentas from births involving different anesthetic drugs were not included in the study, aiming to standardize the procedure.
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No Intervention: control group
The group comprises healthy mothers who meet the inclusion criteria specified in the study, have an 8cm dilation at term, and give birth vaginally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oksitosin Receptor Immunoreactivity
Time Frame: 2 weeks
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After subjecting the placenta samples to various biochemical tests and staining procedures, they were prepared appropriately and evaluated for oxytocin receptor activity after being incubated for 24 hours.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pearson correlation analysis
Time Frame: 1 months
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The collected data included variables such as maternal age, body mass index (BMI), number of abortions, number of abortions, age at first pregnancy, number of live children, date of last menstrual period, and various newborn parameters such as gender, weight, head circumference, length, 1st and 5th minute Apgar scores, anterior-posterior fontanelle opening, placental thickness, weight, major-minor diameter, and total cord length. For the statistical analysis of the collected data, version 20.0 of the SPSS program was utilized. Independent Samples T-Test was applied to compare the means of binary variables and their differences at a significance level of 5%. Pearson correlation analysis was employed to examine the relationships between variables. |
1 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seyit Ali Bingöl, associate professor dr., Kafkas University Faculty of Medicine
- Study Chair: SEVİN Polat, resarch assistant, Kafkas University Faculty of Health Sciences
Publications and helpful links
General Publications
- Aydogan A, Bingol SA. Examination of the immunohistochemical localization and gene expression by RT-PCR of the oxytocin receptor in diabetic and non-diabetic mouse testis. Iran J Basic Med Sci. 2018 Jul;21(7):695-700. doi: 10.22038/IJBMS.2018.28069.6820.
- Szukiewicz D, Bilska A, Mittal TK, Stangret A, Wejman J, Szewczyk G, Pyzlak M, Zamlynski J. Myometrial contractility influences oxytocin receptor (OXTR) expression in term trophoblast cells obtained from the maternal surface of the human placenta. BMC Pregnancy Childbirth. 2015 Sep 16;15:220. doi: 10.1186/s12884-015-0656-3.
- Barker DJ, Thornburg KL, Osmond C, Kajantie E, Eriksson JG. The surface area of the placenta and hypertension in the offspring in later life. Int J Dev Biol. 2010;54(2-3):525-30. doi: 10.1387/ijdb.082760db.
- Buisman-Pijlman FT, Sumracki NM, Gordon JJ, Hull PR, Carter CS, Tops M. Individual differences underlying susceptibility to addiction: Role for the endogenous oxytocin system. Pharmacol Biochem Behav. 2014 Apr;119:22-38. doi: 10.1016/j.pbb.2013.09.005. Epub 2013 Sep 18.
- Alwasel SH, Harrath A, Aljarallah JS, Abotalib Z, Osmond C, Al Omar SY, Khaled I, Barker DJ. Intergenerational effects of in utero exposure to Ramadan in Tunisia. Am J Hum Biol. 2013 May-Jun;25(3):341-3. doi: 10.1002/ajhb.22374. Epub 2013 Feb 21.
- Eriksson JG, Gelow J, Thornburg KL, Osmond C, Laakso M, Uusitupa M, Lindi V, Kajantie E, Barker DJ. Long-term effects of placental growth on overweight and body composition. Int J Pediatr. 2012;2012:324185. doi: 10.1155/2012/324185. Epub 2012 Apr 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 81829502.903/39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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