Maternal Care PatternsNCT05490056
Adequacy of Antenatal Care and Its Determinants in Assiut District
An observational study of Maternal Care Patterns, run by Assiut University.
Trial summary
Cross sectional study on women who gave birth and attend immunization session for their children in Assiut District to assess the adequacy of ANC, its determinants and knowledge and attitude of antenatal care among the studied women Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to Jul 2024
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: This study will be carried on women gave birth and come to immunize their children aged 2 months. The selection of index mother will be done during children vaccination sessions as the high vaccination coverage in Egypt give higher opportunity for non- biased selection of the studied population.
Who may be able to join
- women of reproductive age who gave birth
- -
Who cannot join
- Pregnant and menopaused women
Trial locations and contacts
No sites are listed yet.
About this study
Cross sectional study on women who gave birth and attend immunization session for their children in Assiut District to assess the adequacy of ANC, its determinants and knowledge and attitude of antenatal care among the studied women
Read the detailed description
The World health organization (WHO) estimated that worldwide in 2021, about 211 women died per 100,000 live birth from pregnancy related causes and increasing to 415 on average in the poorest countries (1)Globally in 2020, nearly 2.4 million babies died during the first 28 days of life (2). High coverage of quality Antenatal Care (ANC) can play a crucial role to decrease maternal and child mortality rates and achieve national and global targets related to maternal and child health. ANC received from skilled provider increases maternal and newborn survival and reduces the risk of pregnancy complications and adverse pregnancy outcomes(3) .
New WHO guidelines on antenatal care for a positive pregnancy experience include:
- A minimum of eight contacts are recommended.
- Counselling about healthy eating and keeping physically active during pregnancy.
- Daily oral iron and folic acid supplementation
- Tetanus toxoid vaccination is recommended.
- One ultrasound scan before 24 weeks' gestation.
- Health-care providers should ask all pregnant women about their use of alcohol and other substances(4).
The 2016 WHO prenatal care guidelines for a healthy pregnancy experience reflect a change from the centered ANC model with a prescribed minimum of 4 ANC visits (ANC4+) to a more expanded model that emphasizes contact number, timing, and services(5). At the global and national levels, most currently available data indicate that women receive at least 4 antenatal care visits. There is very limited data on the adequacy of ANC based and their correlates on updated WHO recommendations for antenatal care(5, (6),(7)). The current study is conducted in accordance with the research plan of Public Health and Community Medicine Department- Faculty of Medicine, Assiut University.
- Conditions
- Maternal Care Patterns
- Being tested
- no intervention
- Keywords
- antenatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
the study will not apply on intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of ANC
): Adequacy of ANC among women who gave birth and attend immunization sessions for their children in Assiut District and its determinants based on receiving all the following 11 ANC items at least once:
- adequate number of ANC visits (at least 8 ANC visits)
- early ANC use (1st ANC booking during 1st trimester)
- Provision of ANC by a skilled provider (doctor or trained nurse).
- Measurement of blood pressure
- A blood sample was taken
- urine sample was taken
- Receiving tetanus toxoid
- Weight measurement
- Ultrasound was performed
- Being informed about danger signs of pregnancy
- And receiving health education about nutrition and prescription oral iron and folic acid supplements.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal Care PatternsStudies 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
- Other
- 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, Marwa Fazzaa Hassan Farag, Assiut University
- Investigators
- Mahmoud Attia, Professor, Principal investigator, Assiut Universiyy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490056
- Sponsor's protocol ID
- Adequacy of ANC in Assiut
- Status last verified
- Mar 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Osterman MJK, Martin JA. Timing and Adequacy of Prenatal Care in the United States, 2016. Natl Vital Stat Rep. 2018 May;67(3):1-14.
PubMed 29874159Pugliese-Garcia M, Radovich E, Hassanein N, Campbell OMR, Khalil K, Benova L. Temporal and regional variations in use, equity and quality of antenatal care in Egypt: a repeat cross-sectional analysis using Demographic and Health Surveys. BMC Pregnancy Childbirth. 2019 Jul 26;19(1):268. doi: 10.1186/s12884-019-2409-1.
PubMed 31349804El Aty MA, Meky FA, Morsy M, El Sayed MK. Overall adequacy of antenatal care in Oman: secondary analysis of national reproductive health survey data, 2008. East Mediterr Health J. 2015 Feb 2;20(12):781-8.
PubMed 25664516
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Antenatal Care and Its Determinants in Assiut District
- ClinicalTrials.gov ID
- NCT05490056
- Acronym / sponsor ID
- Adequacy of ANC in Assiut
- Conditions
- Maternal Care Patterns
- Keywords
- antenatal care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Aug 2022 (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.
Cross sectional study on women who gave birth and attend immunization session for their children in Assiut District to assess the adequacy of ANC, its determinants and knowledge and attitude of antenatal care among the studied women
Detailed description
The World health organization (WHO) estimated that worldwide in 2021, about 211 women died per 100,000 live birth from pregnancy related causes and increasing to 415 on average in the poorest countries (1)Globally in 2020, nearly 2.4 million babies died during the first 28 days of life (2). High coverage of quality Antenatal Care (ANC) can play a crucial role to decrease maternal and child mortality rates and achieve national and global targets related to maternal and child health. ANC received from skilled provider increases maternal and newborn survival and reduces the risk of pregnancy complications and adverse pregnancy outcomes(3) .
New WHO guidelines on antenatal care for a positive pregnancy experience include:
- A minimum of eight contacts are recommended.
- Counselling about healthy eating and keeping physically active during pregnancy.
- Daily oral iron and folic acid supplementation
- Tetanus toxoid vaccination is recommended.
- One ultrasound scan before 24 weeks' gestation.
- Health-care providers should ask all pregnant women about their use of alcohol and other substances(4).
The 2016 WHO prenatal care guidelines for a healthy pregnancy experience reflect a change from the centered ANC model with a prescribed minimum of 4 ANC visits (ANC4+) to a more expanded model that emphasizes contact number, timing, and services(5). At the global and national levels, most currently available data indicate that women receive at least 4 antenatal care visits. There is very limited data on the adequacy of ANC based and their correlates on updated WHO recommendations for antenatal care(5, (6),(7)). The current study is conducted in accordance with the research plan of Public Health and Community Medicine Department- Faculty of Medicine, Assiut University.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study will be carried on women gave birth and come to immunize their children aged 2 months. The selection of index mother will be done during children vaccination sessions as the high vaccination coverage in Egypt give higher opportunity for non- biased selection of the studied population.
Key inclusion criteria (2 listed)
- women of reproductive age who gave birth
- -
Key exclusion criteria (1 listed)
- Pregnant and menopaused women
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 |
|---|---|---|
| no interventionthe study will not apply on intervention | Other | – |
Primary outcome
Adequacy of ANC
Time frame: 2 years
): Adequacy of ANC among women who gave birth and attend immunization sessions for their children in Assiut District and its determinants based on receiving all the following 11 ANC items at least once: * adequate number of ANC visits (at least 8 ANC visits) * early ANC use (1st ANC booking during 1st trimester) * Provision of ANC by a skilled provider (doctor or trained nurse). * Measurement of blood pressure * A blood sample was taken * urine sample was taken * Receiving tetanus toxoid * Weight measurement * Ultrasound was performed * Being informed about danger signs of pregnancy * And receiving health education about nutrition and prescription oral iron and folic acid supplements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Results publication: PubMed 29874159Osterman MJK, Martin JA. Timing and Adequacy of Prenatal Care in the United States, 2016. Natl Vital Stat Rep. 2018 May;67(3):1-14.
- Results publication: PubMed 31349804Pugliese-Garcia M, Radovich E, Hassanein N, Campbell OMR, Khalil K, Benova L. Temporal and regional variations in use, equity and quality of antenatal care in Egypt: a repeat cross-sectional analysis using Demographic and Health Surveys. BMC Pregnancy Childbirth. 2019 Jul 26;19(1):268. doi: 10.1186/s12884-019-2409-1.
- Results publication: PubMed 25664516El Aty MA, Meky FA, Morsy M, El Sayed MK. Overall adequacy of antenatal care in Oman: secondary analysis of national reproductive health survey data, 2008. East Mediterr Health J. 2015 Feb 2;20(12):781-8.
- New guidelines on antenatal care for a positive pregnancy experienceLink provided by the sponsor.
- https://www.who.int/news/item/05-10-2021-new-global-targets-to-prevent-maternal-deathsLink provided by the sponsor.
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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 Attia, Professor principal investigator
Assiut Universiyy
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Care Patterns, run by Assiut University.
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 2 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Marwa Fazzaa, physician (01091434853, khadijaalian52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of ANC (time frame: 2 years). 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 NCT05490056, which also lists 3 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 5 Aug 2022.