NCT07413185

Brief Summary

The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration. However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 10, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Breastfeeding Success (LATCH Score)

    Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, which evaluates five domains: latch, audible swallowing, type of nipple, maternal comfort (breast/nipple), and holding/positioning. Each item is scored from 0 to 2, with a total score ranging from 0 to 10. Higher scores indicate greater breastfeeding success.

    Within the first 48 hours postpartum (one-time assessment at enrollment)

  • Insomnia Severity (Insomnia Severity Index, ISI)

    Insomnia severity will be measured using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and distress caused by sleep problems. Each item is scored from 0 to 4, yielding a total score of 0-28. Higher scores indicate more severe insomnia.

    Within the first 48 hours postpartum (one-time assessment at enrollment)

  • Breastfeeding Motivation (Breastfeeding Motivation Scale Subscale Scores)

    Breastfeeding motivation will be evaluated using the Breastfeeding Motivation Scale based on Self-Determination Theory. The scale includes 24 items rated on a 4-point Likert scale and provides scores for five subdomains: integrated regulation, intrinsic motivation/identified regulation, introjected regulation (social approval), introjected regulation (social pressure), and external regulation (secondary benefits). Subscale scores are calculated as the mean of items within each subdomain; higher scores indicate stronger motivation of that type.

    Within the first 48 hours postpartum (one-time assessment at enrollment)

  • Maternal and Neonatal Characteristics (Descriptive Data Form)

    Participant demographic, obstetric, delivery-related, neonatal, breastfeeding history, breastfeeding-related characteristics, and sleep habit information will be collected using a structured descriptive information form developed by the researchers based on the literature.

    Within the first 48 hours postpartum (one-time assessment at enrollment)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of primiparous and multiparous women aged ≥18 years who have delivered a healthy term infant, whose newborn is not admitted to the NICU, and who initiated breastfeeding within the first 48 hours postpartum.

You may qualify if:

  • Primiparous or multiparous women aged 18 years and older
  • Having a healthy term delivery
  • Infant not admitted to the neonatal intensive care unit (NICU)
  • Initiated breastfeeding within the first 48 hours postpartum

You may not qualify if:

  • Complications requiring sedation
  • Severe postpartum hemorrhage
  • Severe postoperative pain or need for narcotic analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Health Group

Istanbul, Altunizade, Turkey (Türkiye)

RECRUITING

Related Publications (8)

  • Altıparmak, S., & Yılmaz, A. N. (2021). The effect of birth type on breastfeeding success and insomnia severity in puerperant women. Samsun Sağlık Bilimleri Dergisi, 6(1), 119-127.

    BACKGROUND
  • Witkowska-Zimny, M., Zhyvotovska, A., Isakov, R., Boiko, D. I., & Nieradko-Iwanicka, B. (2024). Maternal sleeping problems before and after childbirth-A systematic review. International journal of women's health, 345-371.

    BACKGROUND
  • Khadka, R., Hong, S. A., & Chang, Y. S. (2020). Prevalence and determinants of poor sleep quality and depression among postpartum women: a community-based study in Ramechhap district, Nepal. International health, 12(2), 125-131. https://doi.org/10.1093/inthealth/ihz032

    BACKGROUND
  • Jensen, D., Wallace, S., & Kelsay, P. (1994). LATCH: a breastfeeding charting system and documentation tool. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 23(1), 27-32.

    BACKGROUND
  • Boysan, M., Güleç, M., Besiroglu, L., & Kalafat, T. (2010). Uykusuzluk Siddeti Indeksi'nin Türk örneklemindeki psikometrik özellikleri. Anadolu Psikiyatri Dergisi, 11(3), 248.

    BACKGROUND
  • Kestler-Peleg, M., Shamir-Dardikman, M., Hermoni, D., & Ginzburg, K. (2015). Breastfeeding motivation and Self-Determination Theory. Social Science & Medicine, 144, 19-27. doi:10.1016/j.socscimed.2015.09.006

    BACKGROUND
  • Ruan, H., Zhang, Y., Tang, Q., Zhao, X., Zhao, X., Xiang, Y., Geng, W., Feng, Y., & Cai, W. (2022). Sleep duration of lactating mothers and its relationship with feeding pattern, milk macronutrients and related serum factors: A combined longitudinal cohort and cross-sectional study. Frontiers in nutrition, 9, 973291. https://doi.org/10.3389/fnut.2022.973291

    BACKGROUND
  • Kayahan, C., & Ozturk, C. S. (2025). Antenatal and postnatal breastfeeding motivation and self-efficacy in primiparous women: a prospective observational study. European Journal of Pediatrics, 184(10), 631.

    BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Güzin Ünlü Suvari, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

March 12, 2026

Primary Completion (Estimated)

February 23, 2027

Study Completion (Estimated)

February 23, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared due to privacy concerns and the sensitive nature of maternal and infant health information. However, anonymized data may be made available upon reasonable request to the corresponding author after publication of the study results.

Locations