Postpartum PeriodNCT07413185
Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success
An observational study of Postpartum Period and Sleep, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period, Sleep, Breastfeeding
- How many people
- 167 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2026to 23 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Complications requiring sedation
- Severe postpartum hemorrhage
- Severe postoperative pain or need for narcotic analgesics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Health Group
Istanbul, Altunizade
Güzin Ünlü Suvari, M.Sc., +90 ext. 2165004429, guzinnunlu@gmail.com
Merve Coşkun, Ph.D.
About this study
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.
- Conditions
- Postpartum Period, Sleep, Breastfeeding, Motivation, Cesarean Section, Lactation
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within the first 48 hours postpartum (one-time assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Mar 2026
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Ünlü Suvari, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413185
- Sponsor's protocol ID
- 2025-20-750
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
Witkowska-Zimny M, Zhyvotovska A, Isakov R, Boiko DI, Nieradko-Iwanicka B. Maternal Sleeping Problems Before and After Childbirth - A Systematic Review. Int J Womens Health. 2024 Mar 2;16:345-371. doi: 10.2147/IJWH.S446490. eCollection 2024.
PubMed 38455339Khadka R, Hong SA, Chang YS. Prevalence and determinants of poor sleep quality and depression among postpartum women: a community-based study in Ramechhap district, Nepal. Int Health. 2020 Feb 12;12(2):125-131. doi: 10.1093/inthealth/ihz032.
PubMed 31294785Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
PubMed 8176525Boysan, M., Güleç, M., Besiroglu, L., & Kalafat, T. (2010). Uykusuzluk Siddeti Indeksi'nin Türk örneklemindeki psikometrik özellikleri. Anadolu Psikiyatri Dergisi, 11(3), 248.
Kestler-Peleg M, Shamir-Dardikman M, Hermoni D, Ginzburg K. Breastfeeding motivation and Self-Determination Theory. Soc Sci Med. 2015 Nov;144:19-27. doi: 10.1016/j.socscimed.2015.09.006. Epub 2015 Sep 8.
PubMed 26372935Ruan H, Zhang Y, Tang Q, Zhao X, Zhao X, Xiang Y, Geng W, Feng Y, Cai W. 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. Front Nutr. 2022 Aug 30;9:973291. doi: 10.3389/fnut.2022.973291. eCollection 2022.
PubMed 36110402Kayahan C, Ozturk CS. Antenatal and postnatal breastfeeding motivation and self-efficacy in primiparous women: a prospective observational study. Eur J Pediatr. 2025 Sep 23;184(10):631. doi: 10.1007/s00431-025-06481-2.
PubMed 40986135
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success
- ClinicalTrials.gov ID
- NCT07413185
- Acronym / sponsor ID
- 2025-20-750
- Conditions
- Postpartum Period, Sleep, Breastfeeding, Motivation, Cesarean Section, Lactation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 17 Feb 2026 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Complications requiring sedation
- Severe postpartum hemorrhage
- Severe postoperative pain or need for narcotic analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breastfeeding Success (LATCH Score)
Time frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
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.
Insomnia Severity (Insomnia Severity Index, ISI)
Time frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
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.
Breastfeeding Motivation (Breastfeeding Motivation Scale Subscale Scores)
Time frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
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.
Maternal and Neonatal Characteristics (Descriptive Data Form)
Time frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- BackgroundAltıparmak, 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: PubMed 38455339Witkowska-Zimny M, Zhyvotovska A, Isakov R, Boiko DI, Nieradko-Iwanicka B. Maternal Sleeping Problems Before and After Childbirth - A Systematic Review. Int J Womens Health. 2024 Mar 2;16:345-371. doi: 10.2147/IJWH.S446490. eCollection 2024.
- Background: PubMed 31294785Khadka R, Hong SA, Chang YS. Prevalence and determinants of poor sleep quality and depression among postpartum women: a community-based study in Ramechhap district, Nepal. Int Health. 2020 Feb 12;12(2):125-131. doi: 10.1093/inthealth/ihz032.
- Background: PubMed 8176525Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
- BackgroundBoysan, M., Güleç, M., Besiroglu, L., & Kalafat, T. (2010). Uykusuzluk Siddeti Indeksi'nin Türk örneklemindeki psikometrik özellikleri. Anadolu Psikiyatri Dergisi, 11(3), 248.
- Background: PubMed 26372935Kestler-Peleg M, Shamir-Dardikman M, Hermoni D, Ginzburg K. Breastfeeding motivation and Self-Determination Theory. Soc Sci Med. 2015 Nov;144:19-27. doi: 10.1016/j.socscimed.2015.09.006. Epub 2015 Sep 8.
- Background: PubMed 36110402Ruan H, Zhang Y, Tang Q, Zhao X, Zhao X, Xiang Y, Geng W, Feng Y, Cai W. 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. Front Nutr. 2022 Aug 30;9:973291. doi: 10.3389/fnut.2022.973291. eCollection 2022.
- Background: PubMed 40986135Kayahan C, Ozturk CS. Antenatal and postnatal breastfeeding motivation and self-efficacy in primiparous women: a prospective observational study. Eur J Pediatr. 2025 Sep 23;184(10):631. doi: 10.1007/s00431-025-06481-2.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Period and Sleep, run by Acibadem 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Güzin Ünlü Suvari, M.Sc. (+902165004429, guzin.unlu@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Success (LATCH Score) (time frame: Within the first 48 hours postpartum (one-time assessment at enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413185, which also lists 8 linked publications.
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 24 Mar 2026.