Mother-Infant InteractionNCT04396509
Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
An observational study of Mother-Infant Interaction and Postnatal Depression, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. 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
- Mother-Infant Interaction, Postnatal Depression, Postpartum Anxiety
- What is being tested?
- Maternal Attachment Inventory Score
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 10 Jun 2019
- Phase
- Observational
- 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
Study population: Two hundred patients were divided into two groups. 100 women delivered vaginally and another 100 delivered with cesarean section. They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Who may be able to join
- natural pregnancy (without any Assisted reproductive technology (ART) method)
- aged 18 to 45 years
- no adverse obstetric history
Who cannot join
- psychiatric diagnosis
- history of psychiatric drug use
- postpartum blues
- known complications during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).
Read the detailed description
The Maternal Attachment Inventory (MAI) measure maternal love attachment (9). Muller tested the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).
- Being tested
- Maternal Attachment Inventory Score
- Keywords
- The Maternal Attachment Inventory, Postnatal Depression, Postpartum Anxiety
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Attachment Inventory ScoreBehavioural
three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
| Study group | Role | What they receive |
|---|---|---|
| women giving birth by normal vaginal delivery | 100 women delivered vaginally. . They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken. Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method), Receives: Behavioral: Maternal Attachment Inventory Score | |
| women giving birth by c-section | 100 delivered with cesarean section. They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken. Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method), Receives: Behavioral: Maternal Attachment Inventory Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups.
They were examined three month after delivery using Maternal Attachment Inventory (MAI); Each item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment
Measured: 3 months
Secondary outcomes (1)
evaluate the correlations between the MIB scores and their sociodemographic data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-Infant InteractionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396509
- Sponsor's protocol ID
- mai-nsd-c/s
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
- ClinicalTrials.gov ID
- NCT04396509
- Acronym / sponsor ID
- mai-nsd-c/s
- Keywords
- The Maternal Attachment Inventory, Postnatal Depression, Postpartum Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 20 May 2020 (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.
To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).
Detailed description
The Maternal Attachment Inventory (MAI) measure maternal love attachment (9). Muller tested the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women giving birth by normal vaginal delivery | – | Behavioral: Maternal Attachment Inventory Score100 women delivered vaginally. . They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken. Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method), |
| women giving birth by c-section | – | Behavioral: Maternal Attachment Inventory Score100 delivered with cesarean section. They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken. Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method), |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two hundred patients were divided into two groups. 100 women delivered vaginally and another 100 delivered with cesarean section. They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Key inclusion criteria (3 listed)
- natural pregnancy (without any Assisted reproductive technology (ART) method)
- aged 18 to 45 years
- no adverse obstetric history
Key exclusion criteria (4 listed)
- psychiatric diagnosis
- history of psychiatric drug use
- postpartum blues
- known complications during pregnancy
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 |
|---|---|---|
| Maternal Attachment Inventory Scorethree month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken. | Behavioural | women giving birth by c-section, women giving birth by normal vaginal delivery |
Primary outcome
Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups.
Time frame: 3 months
They were examined three month after delivery using Maternal Attachment Inventory (MAI); Each item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment
1 secondary outcome
evaluate the correlations between the MIB scores and their sociodemographic data.
Time frame: 3 months
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 21 May 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mother-Infant Interaction and Postnatal Depression, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 4 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 21 May 2020. 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?
Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups. (time frame: 3 months). 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 21 May 2020.