- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551571
The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO)
The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO) on the Mother's Maternal Behavior Towards Her Baby, Breastfeeding Self-efficacy, Breastfeeding Success, and Hospital Discharge Readiness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42250
- Seyhan Çankaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older,
- History of term pregnancy (38-42 weeks),
- Having a primiparous,
- Single, healthy, vertex positioned fetus,
- Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
- Birth canal dystocia, dystocia related to the mother's psychology),
- Having a partner/husband,
- History of cervical dilatation of 5 cm or more,
- Having a healthy newborn,
- Being able to speak and understand Turkish.
Exclusion Criteria:
- Being under 18 years of age,
- Having a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
- Having a chronic disease (hypertension, diabetes, etc.),
- Having maternal or fetal complications (oligohydramnios and polyhydramnios, placenta previa, pre-eclampsia, premature rupture of membranes, anomalies of presentation, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, cord prolapse, etc.),
- Having any complication that prevents vaginal delivery (head-pelvis incompatibility, etc.),
- Having a history of elective cesarean section,
- Being pregnant with assisted reproductive techniques,
- Being multiparous,and having mastitis in the breast or having inverted nipples.
- The study also excluded women who had undergone a cesarean section due to any complication (e.g., cord entanglement, fetal distress),
- Who experienced complications related to the postpartum period (e.g., uterine atony, hemorrhage),
- And whose infant was admitted to the neonatal intensive care unit for any reason (e.g., respiratory distress).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
|
- The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations
|
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of postpartum characteristics of pregnant women
Time Frame: 6 months
|
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
|
6 months
|
|
Comparison of pre-intervention sociodemographic of pregnant women.
Time Frame: 6 months
|
Sociodemographic of pregnant women will be collected through surveys and compared and reported
|
6 months
|
|
Comparison of pre-intervention obstetric features of pregnant women
Time Frame: 6 months
|
Obstetric of pregnant women will be collected through surveys and compared and reported.
|
6 months
|
|
Comparison of mother's postpartum parenting behavior towards her baby mean scores by groups
Time Frame: 6 months
|
The postpartum parenting behavior scale will be applied to mothers.
The postpartum parenting behavior scale is 0-6 points (min-max) and as the score increases, the level of positive parenting behaviors of mothers towards their babies increases.
|
6 months
|
|
Comparison of mother's breastfeeding self-efficacy scale mean scores by groups
Time Frame: 6 months
|
The breastfeeding self-efficacy scale will be applied to mothers.
The breastfeeding self-efficacy scale is 14-70 points (min-max) and as the score increases, the breastfeeding self-efficacy of the mothers increases.
|
6 months
|
|
Comparison of mother's A Breastfeeding Charting System and Documentation Tool (LATCH) mean scores by groups
Time Frame: 6 months
|
The Breastfeeding Charting System and Documentation Tool (LATCH) will be applied to mothers. The LATCH is 0-10 points (min-max) and as the score increases, the LATCH of the mothers increases. |
6 months
|
|
Comparison of mother's readiness for hospital discharge scale-new mother form mean scores by groups
Time Frame: 6 months
|
The readiness for hospital discharge scale-new motherwill be applied to mothers. The readiness for hospital discharge scale-new mother is 0-220 points (min-max) and as the score increases shows that the mothers is sufficiently ready for discharge. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seyhan Çankaya, PhD, Selcuk University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/1143
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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