Normal LabourNCT06922435
Evaluation of Management and Outcomes of Normal Labor in Eldakhla Hospital
An observational study of Normal Labour, run by Assiut University.
Trial summary
Labour is a physiologic process during which the products of conception are expelled outside of the uterus. Labour is achieved with changes in the biochemical connective tissue and with gradual effacement and dilatation of the uterine cervix as a result of rhythmic uterine contractions of sufficient frequency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Labour
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with full-term labour that included all women who will be fullfilling the following criteria: * Age from 18 -40 years, * gestational age: complete 37 weeks gestation-41ws+6 days, * True labour pain associated with cervical changes, Cervical dilation > 3 cm
Who may be able to join
- Patients with full-term labour that included all women who will be fullfilling the following criteria:
- Age from 18 -40 years,
- gestational age: complete 37 weeks gestation-41ws+6 days,
- True labour pain associated with cervical changes, Cervical dilation > 3 cm
Who cannot join
- Multiple gestations, Fetal malformations, Complicated pregnancy (hypertension, diabetes. etc...), Intrauterine growth restriction or macrosomic fetuses, Antepartum hemorrhage or presence of meconium-stained fluid, Preterm labour and false labour pain.
About this study
Official title: Evaluation of Management and Outcomes of Normal Labor in Eldakhla Hospital.
Labour is a physiologic process during which the products of conception are expelled outside of the uterus. Labour is achieved with changes in the biochemical connective tissue and with gradual effacement and dilatation of the uterine cervix as a result of rhythmic uterine contractions of sufficient frequency, intensity, and duration The WHO definition further stated that the aim of care in normal birth is to achieve a healthy mother and child with the least possible level of interventions, and in every case, there should be a valid reason to interfere with the natural process.
The presence of changes in cervical effacement, dilation, position, consistency, and descent of the presenting part are the key indicators in identifying the stages of labour. Concomitant with the increased frequency of contractions, a patient perceives the descent of the fetus into her pelvis as lightening (3).
Read more
The process from the 1st to the 3rd stage is a continuum without any break. The first stage of labour is the beginning and longest stage and largely determines the outcome of the labour process because commonly, a normal first stage is followed by a normal 2nd and 3rd stages of labour. Hence, in current clinical practice, the management of labour virtually equates to the management of the first stage. The pain associated with labour is a unique and complex phenomenon. Whilst typical experiences of pain tend to be associated with injury or disease, labour pain emerges during a vital and highly positive event. In fact, as the pain intensity rises, the labour is seen to be progressing normally.
The clinical audit is the systematic and critical analysis of the quality of medical care, including the procedures used for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient.
Reviewing of care included three domains "structure, process and outcomes" which are selected and evaluated in a systematic way according to explicit criteria .
This definition highlights two key features of the process of audit. First, audit involves a criticism of current practice. Second audit is not restricted to the technical accuracy of diagnosis or treatment but also involves diverse issues such as for example the timeliness of interventions, the appropriateness of referral, the attitudes of staff or the information given to the patient the aim of the study To improve service and quality for patients of the normal labour in the department of Obstetrics and Gynecology, Dakhla Hospital.
To assess and evaluate the practices, procedures, and outcomes of normal labor.
- Conditions
- Normal Labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with full-term labour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcomes
post-partum hemorrhage percentage
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal LabourStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdel Baset Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922435
- Sponsor's protocol ID
- M &O normal labor Eldakhla
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Management and Outcomes of Normal Labor in Eldakhla Hospital.
- ClinicalTrials.gov ID
- NCT06922435
- Acronym / sponsor ID
- M &O normal labor Eldakhla
- Conditions
- Normal Labour
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
Labour is a physiologic process during which the products of conception are expelled outside of the uterus. Labour is achieved with changes in the biochemical connective tissue and with gradual effacement and dilatation of the uterine cervix as a result of rhythmic uterine contractions of sufficient frequency, intensity, and duration The WHO definition further stated that the aim of care in normal birth is to achieve a healthy mother and child with the least possible level of interventions, and in every case, there should be a valid reason to interfere with the natural process.
The presence of changes in cervical effacement, dilation, position, consistency, and descent of the presenting part are the key indicators in identifying the stages of labour. Concomitant with the increased frequency of contractions, a patient perceives the descent of the fetus into her pelvis as lightening (3).
The process from the 1st to the 3rd stage is a continuum without any break. The first stage of labour is the beginning and longest stage and largely determines the outcome of the labour process because commonly, a normal first stage is followed by a normal 2nd and 3rd stages of labour. Hence, in current clinical practice, the management of labour virtually equates to the management of the first stage. The pain associated with labour is a unique and complex phenomenon. Whilst typical experiences of pain tend to be associated with injury or disease, labour pain emerges during a vital and highly positive event. In fact, as the pain intensity rises, the labour is seen to be progressing normally.
The clinical audit is the systematic and critical analysis of the quality of medical care, including the procedures used for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient.
Reviewing of care included three domains "structure, process and outcomes" which are selected and evaluated in a systematic way according to explicit criteria .
This definition highlights two key features of the process of audit. First, audit involves a criticism of current practice. Second audit is not restricted to the technical accuracy of diagnosis or treatment but also involves diverse issues such as for example the timeliness of interventions, the appropriateness of referral, the attitudes of staff or the information given to the patient the aim of the study To improve service and quality for patients of the normal labour in the department of Obstetrics and Gynecology, Dakhla Hospital.
To assess and evaluate the practices, procedures, and outcomes of normal labor.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients with full-term labour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with full-term labour that included all women who will be fullfilling the following criteria: * Age from 18 -40 years, * gestational age: complete 37 weeks gestation-41ws+6 days, * True labour pain associated with cervical changes, Cervical dilation > 3 cm
Key inclusion criteria (4 listed)
- Patients with full-term labour that included all women who will be fullfilling the following criteria:
Key exclusion criteria (1 listed)
- Multiple gestations, Fetal malformations, Complicated pregnancy (hypertension, diabetes. etc...), Intrauterine growth restriction or macrosomic fetuses, Antepartum hemorrhage or presence of meconium-stained fluid, Preterm labour and false labour pain.
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
Maternal outcomes
Time frame: 7 days
post-partum hemorrhage percentage
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 10 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Labour, 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 4 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: opening soon, as of the sponsor's last update on 10 Apr 2025. 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?
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?
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?
Maternal outcomes (time frame: 7 days). 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 10 Apr 2025.