NCT06551571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 9, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

WHO intrapartum care modelbreastfeeding self-efficacyLATCHparenting behaviordischarge readiness

Outcome Measures

Primary Outcomes (7)

  • Comparison of pre-intervention sociodemographic of pregnant women.

    Sociodemographic of pregnant women will be collected through surveys and compared and reported

    6 months

  • Comparison of pre-intervention obstetric features of pregnant women

    Obstetric of pregnant women will be collected through surveys and compared and reported.

    6 months

  • Comparison of postpartum characteristics of pregnant women

    Postpartum characteristics 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

    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

    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

    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

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL

* 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.

Other: Intrapartum Care Model

Control Group

NO INTERVENTION

* 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.

Interventions

\- 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 Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy ComplicationsBreast Feeding

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Seyhan Çankaya, PhD

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations