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Perinatal MorbidityNCT03928795

Perinatal Morbidity Factors During Cesarean Section

An observational study of Perinatal Morbidity, run by University Tunis El Manar at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Caesarean section is one of the most common surgeries in the world and the increasing rate of cesarean delivery is associated with increased maternal and fetal morbidity when compared to vaginal delivery. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Perinatal Morbidity
What is being tested?
elective caesarean section
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteTunisia
Study dates
27 Aug 2018to 10 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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Was defined by all women with indication of an elective caesarean section in our department during the study period.

Who may be able to join

  • Monofetal pregnancy
  • Age over 18 years old
  • Term Pregnancy ≥ 37SA
  • Indication for Elective caesarean section

Who cannot join

  • -Fetal pathology known prenatally like intrauterine severe growth retardation with Doppler abnormalities, fetal malformation or a known fetal genetic defect.
  • Anomaly of placental adhesion.
  • Caesarean in a context of medical or obstetric emergency.
  • Caesarean section performed under general anesthesia following failure of locoregional anesthesia.
  • Refusal of the woman to participate in the study.
  • Impossibility or failure to study the neonatal acid-base balance on the umbilical cord.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Kaouther Dimassi

    Tunis, Sidi Daoued La Marsa, 2045

Other trials in Tunisia

About this study

Official title: Perinatal Morbidity Factors During Elective Cesarean Section

Caesarean section is one of the most common surgeries in the world and the increasing rate of cesarean delivery is associated with increased maternal and fetal morbidity when compared to vaginal delivery.

With this dramatic increase in caesarean section rates, it is urgent to identify factors that may affect perinatal morbidity. Indeed, such factors can be classified into:

Read more
  • Modifiable factors: surgical technique, anesthesia technique, operator experience, operative time
  • Not modifiable factors: characteristics inherent to the mother: BMI, gravidic pathology, number of caesareans...

Majority of previous studies focused on anesthetic factors. A global vision integrating all parameters is necessary in order to best guide the preventative measures to be put in place.

our Objectives were : To Identify and to Analyze Perinatal Morbidity Factors During Caesarean Section

Read the detailed description

I- Characteristics of the study:

Non-interventional descriptive longitudinal prospective study.

II- Location and period of study:

The study tooked place in the obstetrics and gynecology department of the Mongi Slim La Marsa University Hospital from 27 august 2018 until 10.04.2019.

III- The study population:

Was defined by all women with indication of an elective caesarean section in our department during the study period.

IV-The eligibility criteria:

  1. The inclusion criteria:
  • Monofetal pregnancy
  • Age over 18 years old
  • Term Pregnancy ≥ 37SA
  • Elective caesarean section
  1. The non-inclusion criteria:
  • Fetal pathology known prenatally like intrauterine severe growth retardation with Doppler abnormalities, fetal malformation or a known fetal genetic defect.
  • Anomaly of placental adhesion.
  • Caesarean in a context of medical or obstetric emergency.
  1. Exclusion criteria:
  • Caesarean section performed under general anesthesia following failure of locoregional anesthesia.
  • Refusal of the woman to participate in the study.
  • Impossibility or failure to study the neonatal acid-base balance on the umbilical cord.

V-Investigators:

  1. The resident responsible for the study : He was responsible for the inclusion and collection of preoperative and postoperative data.
  2. Surgeons :

They immediately after surgery reported on the patient information sheet the surgical features of the cesarean section: the technique used, the methods of fetal extraction, the difficulties encountered...

VI- The judgment criteria:

  • The acid-base balance of the newborn that will be evaluated by the measurement of neonatal PH at the umbilical cord and the neonatal eucapnic [1-2-3].
  • The APGAR score at 5 minutes [4]
  • Rates of transfer to neonatal intensive care unit ( NICU) and reason for hospitalization.

VII-The progress of the study:

  1. The pre-inclusion visit All the patients followed at the outpatient clinic were informed of the study during the prenatal visit of the 8th month. The resident responsible for the study checked the eligibility criteria and informed the patient of the research objectives, its progress and the expected benefits of the research. He answered all questions about Cesarean the study. A period of reflection until the day of delivery was left for signing the consent form. (see annexes 1 and 2)
  2. The inclusion visit The resident in charge of the study was responsible for the final verification of the eligibility criteria and obtaining the written informed consent of the patient in Arabic (Appendix 1) and in French (Appendix 2). If the patient agreed to participate, the investigator wrote his name and surname in clear, date and sign the consent form. The patients recruited were chronologically assigned a number until the end of the study.
  3. The day of cesarean section Once the patient had been selected for the study, her delivery was planned according to gestational age and respected the usual recommendations and protocols of use in the department.

Thus, the indication of cesarean delivery and the date of the operation were not affected by the inclusion of the patient in this observational study.

Investigators described the anesthetic and surgical techniques. Thus, the patient file was completed prospectively and specified the items relating to

  • The surgeon:

The rank of the operator and his experience in caesarean surgery.

-Caesarean technique: Indeed, two caesarean techniques are used in our department and the choice between the two was attributed to the operator.

  • The intraperitoneal Misgav Ladach technique [5]
  • Extraperitoneal caesarean section according to the technique "French ambulatory cesarean section" (FAUCS) [6]
  • The different operating times:
  • Time between the beginning of the anesthesia and the incision of the skin.
  • Time between skin incision and fetal extraction.
  • Time between hysterotomy and fetal extraction or actual duration of fetal extraction.
  • The modalities of fetal extraction:
  • fetal presentation
  • Possible use of instruments
  • Use of maneuvers for intraoperative fetal extraction
  • Operator's subjective evaluation of the degree of difficulty encountered to achieve fetal extraction
  • Neonatal outcome:
  • The neonatal PH measured at the umbilical cord.
  • The eucapnic neonatal PH.
  • The Apgar score at 5 minutes.
  • Possible hospitalization in neonatology department and in which case its reason.

VIII-Statistic study:

We performed a correlation Pearson study between the different operating times measured during the study and the value of the neonatal eucapnic PH.

We performed a logistic regression to identify among the used variables the factors that significantly and independently influenced the neonatal outcome. We identified two major events : neonatal ph<7.15 and neonatal ph <7.1

Being tested
elective caesarean section
Keywords
neonatal ph, neonatal eucapnic ph, fetal extraction, elective caesarean, apgar score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elective caesarean sectionProcedure or surgery

    elective caesarean section

Study groups in NCT03928795
Study groupRoleWhat they receive
neonates with acute acidosisneonates with Cord blood gases measured immediately after birth inferior to 7.15
Receives: Procedure: elective caesarean section
neonates with a normal phneonates with Cord blood gases measured immediately after birth of at least 7.15
Receives: Procedure: elective caesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neonatal acid base balance

    Cord blood gases

    Measured: immediately after fetal extraction

Secondary outcomes (1)
  1. apgar score

    The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an ackronym (Appearance, Pulse, Grimace, Activity, Respiration).he test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

    Measured: 1,3,5 and 10 minutes of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study start27 Aug 2018
  3. Primary completion1 Feb 2019
  4. Study completion10 Apr 2019

Resources

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
Prospective
Enrolment
100 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03928795
Sponsor's protocol ID
perinatal morbidity mongi slim
Status last verified
Jan 2020
First submitted
23 Apr 2019
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Perinatal Morbidity, run by University Tunis El Manar at 1 site in Tunisia.

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 6 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 13 Jan 2020. 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 Tunisia. 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?

neonatal acid base balance (time frame: immediately after fetal extraction). 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 13 Jan 2020.

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