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Completed

NCT Number: NCT06681675

The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on the Birth Process and Care

This study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care.

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Key information

Conditions

Birth Outcomes Birth Comfort Birth Period Fear of Birth Labor Pain Labor Pain and to Reduce Pain Neurologic Manifestations Oxytocin Deficiency Pain Pathological Conditions, Signs and Symptoms Perception of Midwifery Care Signs and Symptoms WHO Intrapartum Care Recommendations

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, 42250, Turkey (Türkiye)

About this study

The research is a randomized controlled trial. The research was conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group were given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group received only the standard intrapartum care in the hospital. Data were collected using the personal information form, labor and postpartum follow-up form, Visual Analog Scale (VAS), Labor Comfort Scale (DKS), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Childbirth Scale. VAS, DKS, and Fear of Childbirth scale were applied to women in both groups when cervical dilation was 5 cm and 9 cm. After birth, the Women's Perception of Supportive Care Given During Childbirth scale was applied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,
  • Being able to speak and understand Turkish

Exclusion criteria

  • Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, etc.),
  • Those with any complications that prevent vaginal delivery,
  • Elective caesarean section, those who became pregnant with assisted reproductive techniques,
  • Those who are multiparous,
  • Those who have chronic diseases (such as hypertension, diabetes, heart disease).

Treatment and study plan

The group that applied the Intrapartum Care Model

Procedure

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.

Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied.

Primary outcomes

  1. 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

  2. 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.

  3. Comparison of labor characteristics of pregnant women before intervention

    Time frame: 6 months

    Labor Characteristics of pregnant women will be collected through questionnaires and compared and reported.

  4. 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.

  5. Comparison of duration of labor of groups

    Time frame: 6 months

    The duration of labor of the groups will be collected through surveys and compared and reported.

  6. Comparison of pregnant women's VAS (pain perception) mean scores by groups

    Time frame: 6 months

    VAS (pain perception) scale will be applied to pregnant women. The pain scale (VAS) is 1-10 points (min-max), and as the score increases, women's pain perception also increases.

  7. Comparison of pregnant women's fear of childbirth average scores by groups

    Time frame: 6 months

    A fear of childbirth scale will be applied to pregnant women. The fear of childbirth scale is 10-100 points (min-max), and as the score increases, women's fear of childbirth increases.

  8. Comparison of pregnant women's birth comfort score averages by groups

    Time frame: 6 months

    A birth comfort scale will be applied to pregnant women. The birth comfort scale is 9-45 points (min-max), and as the score increases, women's birth comfort increases.

  9. Comparison of mean scores of the scale of women's perception of supportive care given during childbirth by groups

    Time frame: 6 months

    A scale of women's perception of supportive care given during childbirth will be applied to pregnant women. The scale of women's perception of supportive care given during childbirth is 33-132 points (min-max), and as the score increases, women's perception of care increases.

  10. Comparison of oxytocin use by groups

    Time frame: 6 months

    Oxytocin use by groups will be collected via survey and reported by comparison.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on Labor Pain, Fear, Comfort, Duration, Oxytocin Use and Midwifery Care Perception: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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