Childbirth ProblemsNCT06123247
Mothers' Respect/Mistreatment During Pregnancy & Childbirth
An observational study of Childbirth Problems and Pregnancy Related, run by Assiut University at 1 site in Egypt.
Trial summary
Pregnancy and childbirth are important events in a woman's and family's life and a time of great vulnerability for every country and culture on earth. Although the concept of "safe motherhood" is often limited to physical safety, the birth of a child is also an important life milestone for women and their familiesin… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems, Pregnancy Related
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2023to Apr 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: study will be conducted in two urban and two rural maternity and child health centers selected randomly from Assiut governorate We will recruit women who have given birth (either vaginal or Cesarean deliveries) within 8 weeks since their Last delivery
Who may be able to join
- Women who have delivered (either vaginally or cesarean) in the past 8 weeks.
Who cannot join
- Women who had complicated childbirth, or stillbirth/neonatal death during their Last delivery will be excluded. In addition, women with known psychiatric illness . These women will be excluded . women who refuse to participate in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
mahmoud abdelaleem, doctorate, +201018880201, mahaleem2000@yahoo.co.uk
About this study
Official title: Mothers' Perception Of Respect/Mistreatment During Pregnancy & Childbirth In Assiut Governorate
Pregnancy and childbirth are important events in a woman's and family's life and a time of great vulnerability for every country and culture on earth. Although the concept of "safe motherhood" is often limited to physical safety, the birth of a child is also an important life milestone for women and their familiesin our study for ssessing the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt and Exploring the factors associated with respectful maternity care and mistreatment among Egyptian women in Assiut governorate in rural and urban areas .
Read the detailed description
A woman's experience with childbirth care is an important factor in her future decisions about whether to receive health care through a health care facility. Women's negative encounters with health workers long-term injury and emotional trauma can result during childbirth. Every woman has several rights. They include the following rights: 1- Freedom from harm and abuse, 2- Information, informed consent and refusal, and respect for women's choices and preferences, including companion during childbirth, 3- Privacy and confidentiality 4) Respectful and dignified treatment 5 - Equality, non-discrimination and appropriate care 6- Healthcare and attainable high standards of health and 7- Freedom, autonomy, self-determination and non-coercion. Reported forms of disrespect and abuse fell into seven categories: physical abuse, non-consensual care, non-confidential care, indecent care, discrimination based on patient characteristics, abandonment of care, and incarceration in institutions.. RMC focuses on eliminating unhealthy and abusive behaviors by healthcare providers and associated personnel, and providing a sensitive and encouraging work environment to help women feel satisfied during childbirth.To measure women's experience of respectful maternity care, vedam et la developed Mothers on Respect Index (MORi) assesses the nature of patient-provider interactions and their impact on human feelings of respect during obstetric care .The mistreatment index (MIST index), which is an indicator of abuse consistent with the seven dimensions ( physical abuse, sexual abuse, verbal abuse, stigma and discrimination. Failure to meet professional standards of care, poor rapport during interactions with Providors, and the poor state and limitations of the healthcare system )
- Conditions
- Childbirth Problems, Pregnancy Related
- Keywords
- respect, mistreatment, mothers
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt
questionnaire including mothers of respect index and mistreatment index
Measured: within 8 weeks after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start20 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdelrahman Mohamed, Assiut University
- Investigators
- mahmoud zakhira, professor, Study director, obstetrics &gynacology depatmen ,assiut universitymoustfa alsonbaty, doctorate, Study chair, obstetrics & gynacology depatmen assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123247
- Sponsor's protocol ID
- 04-2023-200266
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Housseine N, Rijken MJ, Punt MC, Meguid T, Franx A, van der Graaf R, Browne JL. Mistreatment during childbirth. Lancet. 2020 Sep 19;396(10254):816-817. doi: 10.1016/S0140-6736(20)31556-7. No abstract available.
PubMed 32950087Vogel JP, Bohren MA, Tuncalp Ӧ, Oladapo OT, Gulmezoglu AM. Promoting respect and preventing mistreatment during childbirth. BJOG. 2016 Apr;123(5):671-4. doi: 10.1111/1471-0528.13750. Epub 2015 Dec 1. No abstract available.
PubMed 26628382Galle A, Manaharlal H, Cumbane E, Picardo J, Griffin S, Osman N, Roelens K, Degomme O. Disrespect and abuse during facility-based childbirth in southern Mozambique: a cross-sectional study. BMC Pregnancy Childbirth. 2019 Oct 22;19(1):369. doi: 10.1186/s12884-019-2532-z.
PubMed 31640603Savage V, Castro A. Measuring mistreatment of women during childbirth: a review of terminology and methodological approaches. Reprod Health. 2017 Oct 26;14(1):138. doi: 10.1186/s12978-017-0403-5.
PubMed 29073914
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers' Perception Of Respect/Mistreatment During Pregnancy & Childbirth In Assiut Governorate
- ClinicalTrials.gov ID
- NCT06123247
- Acronym / sponsor ID
- 04-2023-200266
- Conditions
- Childbirth Problems, Pregnancy Related
- Keywords
- respect, mistreatment, mothers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 8 Nov 2023 (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.
Pregnancy and childbirth are important events in a woman's and family's life and a time of great vulnerability for every country and culture on earth. Although the concept of "safe motherhood" is often limited to physical safety, the birth of a child is also an important life milestone for women and their familiesin our study for ssessing the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt and Exploring the factors associated with respectful maternity care and mistreatment among Egyptian women in Assiut governorate in rural and urban areas .
Detailed description
A woman's experience with childbirth care is an important factor in her future decisions about whether to receive health care through a health care facility. Women's negative encounters with health workers long-term injury and emotional trauma can result during childbirth. Every woman has several rights. They include the following rights: 1- Freedom from harm and abuse, 2- Information, informed consent and refusal, and respect for women's choices and preferences, including companion during childbirth, 3- Privacy and confidentiality 4) Respectful and dignified treatment 5 - Equality, non-discrimination and appropriate care 6- Healthcare and attainable high standards of health and 7- Freedom, autonomy, self-determination and non-coercion. Reported forms of disrespect and abuse fell into seven categories: physical abuse, non-consensual care, non-confidential care, indecent care, discrimination based on patient characteristics, abandonment of care, and incarceration in institutions.. RMC focuses on eliminating unhealthy and abusive behaviors by healthcare providers and associated personnel, and providing a sensitive and encouraging work environment to help women feel satisfied during childbirth.To measure women's experience of respectful maternity care, vedam et la developed Mothers on Respect Index (MORi) assesses the nature of patient-provider interactions and their impact on human feelings of respect during obstetric care .The mistreatment index (MIST index), which is an indicator of abuse consistent with the seven dimensions ( physical abuse, sexual abuse, verbal abuse, stigma and discrimination. Failure to meet professional standards of care, poor rapport during interactions with Providors, and the poor state and limitations of the healthcare system )
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- study will be conducted in two urban and two rural maternity and child health centers selected randomly from Assiut governorate We will recruit women who have given birth (either vaginal or Cesarean deliveries) within 8 weeks since their Last delivery
Key inclusion criteria (1 listed)
- Women who have delivered (either vaginally or cesarean) in the past 8 weeks.
Key exclusion criteria (1 listed)
- Women who had complicated childbirth, or stillbirth/neonatal death during their Last delivery will be excluded. In addition, women with known psychiatric illness . These women will be excluded . women who refuse to participate in the study will be excluded.
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
measurement the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt
Time frame: within 8 weeks after childbirth
questionnaire including mothers of respect index and mistreatment index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 32950087Housseine N, Rijken MJ, Punt MC, Meguid T, Franx A, van der Graaf R, Browne JL. Mistreatment during childbirth. Lancet. 2020 Sep 19;396(10254):816-817. doi: 10.1016/S0140-6736(20)31556-7. No abstract available.
- Background: PubMed 26628382Vogel JP, Bohren MA, Tuncalp Ӧ, Oladapo OT, Gulmezoglu AM. Promoting respect and preventing mistreatment during childbirth. BJOG. 2016 Apr;123(5):671-4. doi: 10.1111/1471-0528.13750. Epub 2015 Dec 1. No abstract available.
- Background: PubMed 31640603Galle A, Manaharlal H, Cumbane E, Picardo J, Griffin S, Osman N, Roelens K, Degomme O. Disrespect and abuse during facility-based childbirth in southern Mozambique: a cross-sectional study. BMC Pregnancy Childbirth. 2019 Oct 22;19(1):369. doi: 10.1186/s12884-019-2532-z.
- Background: PubMed 29073914Savage V, Castro A. Measuring mistreatment of women during childbirth: a review of terminology and methodological approaches. Reprod Health. 2017 Oct 26;14(1):138. doi: 10.1186/s12978-017-0403-5.
- Individual participant dataSharing planned: Undecided
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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.
mahmoud zakhira, professor study director
obstetrics &gynacology depatmen ,assiut university
moustfa alsonbaty, doctorate study chair
obstetrics & gynacology depatmen assiut university
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 Childbirth Problems and Pregnancy Related, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fatma mohamed (00201279969493, drfatma076@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt (time frame: within 8 weeks after childbirth). 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 NCT06123247, which also lists 4 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 21 Nov 2023.