Delivery ,Complications,MaternalNCT03666078
Assessment of Maternal and Perinatal Morbidity and Mortality in Vaginal and Cesarean Delivery
An observational study of Delivery ,Complications,Maternal and Delivery,Complication,Fetal, run by Alzahraa Ismail Ragheb Goda at 1 site in Egypt.
Trial summary
This study will be done at Ain Shams university maternity hospital to identify the significant risk of maternal intensive care unit admission, need for advanced surgery, postpartum hemorrhage, need for blood transfusion, febrile morbidity, neonatal intensive care unit admission (NICU), need for neonatal intubation and… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Delivery ,Complications,Maternal, Delivery,Complication,Fetal
- What is being tested?
- cesarean delivery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2018to 1 Apr 2019
- How long will I take part?
- 2 Days
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Study population: all women who delivered vaginally and by cesarean section at Ain Shams maternity hospital will be included.
Who may be able to join
- All of the patients who will deliver vaginally
- All of the patients who will deliver by cesarean sections.
Who cannot join
- no exclusion criteria, all women who will attend for delivery will be included.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams maternity hospital
Cairo, 11566
abd el fatah soaod, proffesor, +226834576, viced.research@med.asu.edu.eg
About this study
Official title: Assessment of Maternal and Perinatal Morbidity and Mortality in Vaginal and Cesarean Delivery Among a Sample of Women Delivering at Ain Shams University Maternity Hospital
This study will be done at Ain Shams university maternity hospital to identify the significant risk of maternal intensive care unit admission, need for advanced surgery, postpartum hemorrhage, need for blood transfusion, febrile morbidity, neonatal intensive care unit admission (NICU), need for neonatal intubation and low APGAR scoring in both vaginal and cesarean section .and this will lead us to know if cesarean section rates in our unit is a safe alternative to vaginal delivery and which of both maneuvers will introduce fewer hazards to mother and fetus.
Read the detailed description
- Type of Study: a cross-sectional study
- Study Setting: Ain Shams maternity hospital
- Study Period: 6 months
- Study Population: in this prospective study, all women who deliver vaginally and by cesarean section at Ain Shams maternity hospital will be included.
- Sampling Method: All of the pregnant women who will deliver vaginally and all of pregnant women who will deliver by cesarean sections in the labor delivery room at Ain Shams University Maternity Hospital on a fixed day and by a fixed team over a period of 6 months
- Sample Size: all pregnant women who will deliver at Ain Shams maternity hospital.
- Inclusion criteria :
- All of the patients who will deliver vaginally
- All of the patients who will deliver by cesarean sections.
- Exclusion criteria: no exclusion criteria, all women who will attend for delivery will be included.
- Ethical Considerations: the study objectives will be briefly and clearly described to all participants and an oral consent will be obtained from all patients.
- Study Procedures :
In all selected cases the following will be recorded:
Parameters of maternal morbidity:
- ICU admission due to the complication of delivery.
- Need for advanced surgery (int. iliac ligation -hysterectomy -or due to the injury of pelvic organs).
- Febrile morbidity temp \>38C on two or more occasion within 48h of delivery.
- Postpartum hemorrhage (blood loss 500cc in VD and 1liter in C\S).
- Wound infection.
- Late complications e.g. (D.V.T-puerperal sepsis and hematoma).
- Need for blood transfusion post labor
- Maternal mortality.
Parameters of fetal morbidity:
- Intracranial hemorrhage as compilations of delivery.
- Neonatal ICU admission as compilations of delivery
- Fracture (Femur, ribs, and humorous)
- Meconium aspiration.
- Erb's palsy.
- APGARscore1-5.
- Need for intubation during resuscitation.
- Statistical analysis The patient will be subdivided into 4 groups, normal VD, instrumental VD, emergency C\S, and elective C\S The data has been collected in analytical sheet tabulated and statistical analysis using the following tests
1- T-test. 2- Chi-square test. 3- Fisher exact test
Statistical package :
data analysis will be performed by SPSS 16.0 using descriptive statistics tools, including mean, standard deviation and figures.A t-test will be used to compare mean values of the two groups .P-values, smaller than 0.05, were considered statistically significant.
- Being tested
- cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean deliveryProcedure or surgery
women delivered by cesarean section
| Study group | Role | What they receive |
|---|---|---|
| normal vaginal delivery | Not described | |
| assisted vaginal delivery | Not described | |
| elective cesarean delivery | Not described Receives: Procedure: cesarean delivery | |
| emergency cesarean delivery | Not described Receives: Procedure: cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
labor and delivery outcome
document maternal and perinatal morbidity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start15 Jul 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ,Complications,MaternalStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Alzahraa Ismail Ragheb Goda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alzahraa Ismail Ragheb Goda, Ain Shams Maternity Hospital
- Investigators
- Tamer F Borg, professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666078
- Sponsor's protocol ID
- zahra2018
- Status last verified
- Jan 2019
- First submitted
- 10 Sep 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maternal and Perinatal Morbidity and Mortality in Vaginal and Cesarean Delivery Among a Sample of Women Delivering at Ain Shams University Maternity Hospital
- ClinicalTrials.gov ID
- NCT03666078
- Acronym / sponsor ID
- zahra2018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alzahraa Ismail Ragheb GodaUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 11 Sep 2018 (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.
This study will be done at Ain Shams university maternity hospital to identify the significant risk of maternal intensive care unit admission, need for advanced surgery, postpartum hemorrhage, need for blood transfusion, febrile morbidity, neonatal intensive care unit admission (NICU), need for neonatal intubation and low APGAR scoring in both vaginal and cesarean section .and this will lead us to know if cesarean section rates in our unit is a safe alternative to vaginal delivery and which of both maneuvers will introduce fewer hazards to mother and fetus.
Detailed description
- Type of Study: a cross-sectional study
- Study Setting: Ain Shams maternity hospital
- Study Period: 6 months
- Study Population: in this prospective study, all women who deliver vaginally and by cesarean section at Ain Shams maternity hospital will be included.
- Sampling Method: All of the pregnant women who will deliver vaginally and all of pregnant women who will deliver by cesarean sections in the labor delivery room at Ain Shams University Maternity Hospital on a fixed day and by a fixed team over a period of 6 months
- Sample Size: all pregnant women who will deliver at Ain Shams maternity hospital.
- Inclusion criteria :
- All of the patients who will deliver vaginally
- All of the patients who will deliver by cesarean sections.
- Exclusion criteria: no exclusion criteria, all women who will attend for delivery will be included.
- Ethical Considerations: the study objectives will be briefly and clearly described to all participants and an oral consent will be obtained from all patients.
- Study Procedures :
In all selected cases the following will be recorded:
Parameters of maternal morbidity:
- ICU admission due to the complication of delivery.
- Need for advanced surgery (int. iliac ligation -hysterectomy -or due to the injury of pelvic organs).
- Febrile morbidity temp \>38C on two or more occasion within 48h of delivery.
- Postpartum hemorrhage (blood loss 500cc in VD and 1liter in C\S).
- Wound infection.
- Late complications e.g. (D.V.T-puerperal sepsis and hematoma).
- Need for blood transfusion post labor
- Maternal mortality.
Parameters of fetal morbidity:
- Intracranial hemorrhage as compilations of delivery.
- Neonatal ICU admission as compilations of delivery
- Fracture (Femur, ribs, and humorous)
- Meconium aspiration.
- Erb's palsy.
- APGARscore1-5.
- Need for intubation during resuscitation.
- Statistical analysis The patient will be subdivided into 4 groups, normal VD, instrumental VD, emergency C\S, and elective C\S The data has been collected in analytical sheet tabulated and statistical analysis using the following tests
1- T-test. 2- Chi-square test. 3- Fisher exact test
Statistical package :
data analysis will be performed by SPSS 16.0 using descriptive statistics tools, including mean, standard deviation and figures.A t-test will be used to compare mean values of the two groups .P-values, smaller than 0.05, were considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal vaginal delivery | – | – |
| assisted vaginal delivery | – | – |
| elective cesarean delivery | – | Procedure: cesarean delivery |
| emergency cesarean delivery | – | Procedure: cesarean delivery |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all women who delivered vaginally and by cesarean section at Ain Shams maternity hospital will be included.
Key inclusion criteria (2 listed)
- All of the patients who will deliver vaginally
- All of the patients who will deliver by cesarean sections.
Key exclusion criteria (1 listed)
- no exclusion criteria, all women who will attend for delivery will be included.
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 |
|---|---|---|
| cesarean deliverywomen delivered by cesarean section | Procedure or surgery | elective cesarean delivery, emergency cesarean delivery |
Primary outcome
labor and delivery outcome
Time frame: 24 hours
document maternal and perinatal morbidity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Tamer F Borg, professor principal investigator
Ain Shams 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 Delivery ,Complications,Maternal and Delivery,Complication,Fetal, run by Alzahraa Ismail Ragheb Goda 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 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 15 Jan 2019. 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 Mohamed M Samy, MD (01001947488, Mohammedsamy8132@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
labor and delivery outcome (time frame: 24 hours). 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 15 Jan 2019.