The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO)

NCT ID: NCT06551571

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-06-01

Brief Summary

The objective of this study was to examine the impact of the intrapartum care model that adheres to the guidelines set forth by the World Health Organization (WHO) on several key outcomes, including the mother's maternal behavior towards her infant postpartum, breastfeeding self-efficacy, the success of breastfeeding, and the mother's readiness for hospital discharge.

Detailed Description

The study was a randomized controlled trial. The study was conducted with 128 primiparous pregnant women (intervention group n=64, control group n=64) admitted to the maternity unit of a training and research hospital in a province in the Central Anatolia region of Turkey. Pregnant women in the intervention group were provided with intrapartum care in accordance with the WHO recommendations following the achievement of cervical dilatation reaching 5 cm. The control group was provided with only standard intrapartum and postpartum care. Data were collected using a personal information form, a postpartum parenting behavior scale, a breastfeeding self-efficacy scale, a breastfeeding charting system and documentation tool (LATCH), and a hospital discharge readiness scale.

Conditions

Birth Outcome, Adverse; Breast Feeding; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

• In pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission.
• 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.
• The Postpartum Parenting Behavior Scale (PPBS), Breastfeeding Self-efficacy Scale (BSS), A Breastfeeding Charting System and Documentation Tool (LATCH), and Readiness for Hospital Discharge Scale-New Mother Form (RHD-NMF) were administered postpartum.

Group Type: EXPERIMENTAL

Intrapartum Care Model

Intervention Type: OTHER

\- 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

Control Group

• Routine intrapartum care was provided to the pregnant woman in the hospital setting. This included taking an anamnesis, completing her file, opening an intravenous line, conducting routine blood tests, taking vital signs, recording cervical changes on the partograph via vaginal examination, applying EFM (electronic fetal monitoring) when indicated according to the attending physician's orders, listening to the fetal heart sounds (FHR) every fifteen minutes, and documenting this on the partograph.
• The mother and infant received standard postpartum care in the hospital. Breastfeeding was initiated immediately after delivery, and the infant was placed in direct contact with the mother. The uterine tone and bleeding of the mother were evaluated, and vital signs were taken every four hours. Nutrition and mobilization were ensured, and a heel prick blood sample was taken in the 24th hour after delivery. If the mother and infant were normal after 24 hours, they were discharged.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intrapartum Care Model

\- 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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Seyhan Çankaya

Assoc. Prof. Seyhan Çankaya

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyhan Çankaya, PhD

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Seyhan Çankaya

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/1143

Identifier Type: -

Identifier Source: org_study_id