Birth Outcome, AdverseNCT06551571
The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO)
A study testing Intrapartum Care Model in people with Birth Outcome, Adverse and Breast Feeding, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Outcome, Adverse, Breast Feeding, Parenting
- What is being tested?
- Intrapartum Care Model
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
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- Having a partner/husband,
- History of cervical dilatation of 5 cm or more,
- Having a healthy newborn,
- Being able to speak and understand Turkish.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Intrapartum Care Model
- Keywords
- WHO intrapartum care model, breastfeeding self-efficacy, LATCH, parenting behavior, discharge readiness
- Medical subject headings
- Pregnancy Complications, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapartum Care ModelOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pre-intervention sociodemographic of pregnant women.
Sociodemographic of pregnant women will be collected through surveys and compared and reported
Measured: 6 months
Comparison of pre-intervention obstetric features of pregnant women
Obstetric of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of postpartum characteristics of pregnant women
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Outcome, AdverseStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
- Investigators
- Seyhan Çankaya, PhD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551571
- Sponsor's protocol ID
- 2023/1143
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06551571
- Acronym / sponsor ID
- 2023/1143
- Conditions
- Birth Outcome, Adverse, Breast Feeding, Parenting
- Keywords
- WHO intrapartum care model, breastfeeding self-efficacy, LATCH, parenting behavior, discharge readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intrapartum Care Model* 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (11 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention Group |
Primary outcome
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
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyhan Çankaya, PhD principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapartum Care Model in people with Birth Outcome, Adverse and Breast Feeding, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pre-intervention sociodemographic of pregnant women. (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.