Antenatal CareANCNCT02663765
Lack of Antenatal Care in Primiparas
An observational study of Antenatal Care, run by Assiut University at 1 site in Egypt.
Trial summary
Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality rate because adequate utilization of antenatal health care services is associated with improved maternal and neonatal health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Antenatal Care
- How many people
- 512 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Dec 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: primiparas who will be delivered in Assiut Women Health Hospital
Who may be able to join
- Women who agree to participate in the study
- Primipara.
Who cannot join
- Multipara.
- Women who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lack of Antenatal Care in Primiparas on Maternal and Perinatal Outcomes
Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality rate because adequate utilization of antenatal health care services is associated with improved maternal and neonatal health outcomes. The trend of maternal mortality in developing countries has been increasing and various international organizations have reported that an important factor related to maternal and infant mortality has been linked to lack of antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to decrease these mortality rates, regular antenatal care has to be instituted or reinforced which can only be achieved through identifying factors causing poor utilization of antenatal care services
- Conditions
- Antenatal Care
What is being measured
The primary outcome is the main question the study is designed to answer.
number of morbidity cases due to lack of antenatal care
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal CareStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663765
- Sponsor's protocol ID
- ANC
- Acronym
- ANC
- Status last verified
- Dec 2016
- First submitted
- 22 Jan 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lack of Antenatal Care in Primiparas on Maternal and Perinatal Outcomes
- ClinicalTrials.gov ID
- NCT02663765
- Acronym / sponsor ID
- ANC / ANC
- Conditions
- Antenatal Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality rate because adequate utilization of antenatal health care services is associated with improved maternal and neonatal health outcomes. The trend of maternal mortality in developing countries has been increasing and various international organizations have reported that an important factor related to maternal and infant mortality has been linked to lack of antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to decrease these mortality rates, regular antenatal care has to be instituted or reinforced which can only be achieved through identifying factors causing poor utilization of antenatal care services
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primiparas who will be delivered in Assiut Women Health Hospital
Key inclusion criteria (2 listed)
- Women who agree to participate in the study
- Primipara.
Key exclusion criteria (2 listed)
- Multipara.
- Women who refuse to participate in the study.
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
number of morbidity cases due to lack of antenatal care
Time frame: 9 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 20 Dec 2016.
- Individual participant dataSharing planned: No
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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 Antenatal Care, 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 2 inclusion and 2 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 20 Dec 2016. 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?
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?
number of morbidity cases due to lack of antenatal care (time frame: 9 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 20 Dec 2016.