French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
Phase: NA
Conditions: Cesarean Section
Sponsor: University Tunis El Manar

 
Study identification : NCT03741907 
TiTle : Comparing French Ambulatory and MISGAV-LADACH
  
 
 
 
 
 
C-Section Techniques  
Principal investigator : Professor kaouther dimassi  
                                          kaouther.dimassi@fmt.utm.tn 
Location : Mongi Slim University Hospital , La Marsa , TUNISIA  
Date of approval​ : 05.05.2018 
 
 
 
 
 
 
 
 
 
 

 
 
 
STUDY PROTOCOL 
This study is a randomized clinical trial conducted at Mongi Slim University Hospital, La
 
 
  
 
 
 
 
 
 
 
 
 
 
Marsa, Tunisia; between August 2018 and January 2019.  
The study was approved by the local hospital ethics committee (reference number 05/18)
 
 
 
 
 
 
 
 
 
 
 
 
 
and was registered at clinicaltrials.gov (NCT03741907). Data collection was conducted in
 
 
 
 
 
 
 
 
 
 
 
compliance with Tunisian laws regarding personal data protection.  
 
During the study period, women with a singleton pregnancy and an elective CS
 
 
 
 
 
  
 
 
 
 
 
 
indication were eligible. There were no restrictions regarding the number of previous CS,
 
 
 
 
 
 
 
 
 
 
 
 
 
fetal presentation or fetal weight. Following subjects were not included in the sample:
 
 
 
 
 
 
 
 
 
 
 
 
 
women under 37 weeks of gestation, women with a prenatally diagnosed fetal pathology
 
 
 
 
 
 
 
  
 
 
 
 
(intrauterine growth restriction, malformation, genetics disorders), a morbidity adherent
 
 
 
 
 
  
 
 
placenta, an adnexal mass or a myoma in the lower uterine segment. 
All women who met the inclusion criteria were invited to participate in the study during their
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
final prenatal visit. Those providing written informed consent were consecutively included in
 
 
 
 
 
 
 
 
 
 
  
a preliminary patient list managed by an investigator not involved in patient care.  
Before randomization, we excluded women who were initially recruited but who had to be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
operated either as an emergency before the originally scheduled date (example: in case of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
acute fetal compromise) or by a different surgeon than those assigned to the study (Figure
 
 
 
 
  
 
 
 
 
 
 
 
 
 

1). Women recruited into the study were given a study number on theirdelivery day, ina
 
 
 
 
 
 
 
  
 
 
 
 
 
 
chronological order. 
All participants were randomly assigned to either FAUCS or MLC group. Group allocation was
 
 
 
 
 
 
 
 
 
 
 
 
 
 
predetermined by an investigator who was not involved in patients care and using the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kendall B.B Smith table ​⁷​. 
The participants as well as, the residents involved in patient care, and the investigators were
 
 
 
 
 
 
 
  
 
 
 
 
 
 
blinded to the cesarean technique before the operation and were informed at discharge.
 
 
 
 
 
 
 
 
 
 
 
 
 
Both anesthetists and surgeons were informed of the cesarean technique on the due date in
 
 
 
 
 
 
 
 
 
 
 
 
 
  
the operating room. 
The MLC spinal anesthesia protocol included 500cc of isotonic crystalloid solution for vascular
 
 
 
 
 
 
 
 
 
 
 
 
 
filling, bupivacaine 7 to 10 milligrams (depending on the patient’s height), morphine 100
 
  
 
 
 
 
 
 
 
 
 
 
micrograms, and sufentanil 10 micrograms.  
The FAUCS spinal anesthesia protocol included no vascular filling, no morphine, bupivacaine
 
 
 
 
 
 
 
 
 
 
 
 
7 to 10 mg (depending on the patient’s height), and sufentanil 10 micrograms. 
A bladder catheterization was performed on the MLC group by using a 16 or 18-F catheter
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
prior to the skin incision. In both groups, a single dose of a first-generation cephalosporin
 
 
 
 
 
 
 
  
 
 
  
 
 
was administered intravenously. 
All FAUCS surgeries were performed by two senior surgeons (K.D and A.H). Both were
 
 
 
 
 
 
 
 
 
 
 
 
 
 
experienced with the paravesical approach and had performed more than 30 cases
 
 
 
 
 
 
 
 
 
 
 
 
previously. The MLC cesarean operations were performed by same seniors or residents who
 
 
 
 
 
 
 
 
 
 
 
 
 
performed vast majority of the operations in the unit. 
For this study, we performed the MLC technique as described in 1999 ³.Regarding the FAUCS
 
 
 
 
 
 
 
 
 
  
 
 
 
 
approach described in 2017, the use of skin glue for closure is recommended ​⁶​. In order to
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 

ensure that all the patients were virtually indistinguishable, we alternatively employed a
 
 
 
 
 
 
 
 
 
 
  
subcuticular absorbable Vicryl suture for the skin closure. 
Hematocrit levels were assessed before and after surgery. Analgesics were administered by
 
 
 
 
 
 
 
 
 
 
 
 
the nursing staff, upon patient’s requests and ​visual analogue scale (VAS)
. ​Assessments
 
 
 
 
 
 
 
 
 
 
 8    
 
with VAS were made every 6 hours: H0,H6,H12,H18, and H24. A standardized analgesics
 
 
 
 
  
 
 
 
  
 
 
scheme was used: 
First intention: 100 mg Ketoprofen intra-rectal route every 6 hours.  
Second intention: intra venous1g paracetamol every 6 hours.  
Third intention: tramadol 50 mg oral route every 6 hours. 
 A first standing was proposed to all women everyhour during the first post operative day. 
The bladder catheter was removed as soon as the woman was able to walk alone.Normal
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
oral food intake was initiated as soon as gas passage occurred and the patient felt hungry. 
Women were evaluated by the end of the first day. If there were no complications and if the
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
patient felt autonomous and pain-free, they were discharged 24 hours after the surgery. In
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the other cases, patients were discharged at least 48 hours after surgery after a similar
 
 
 
 
 
 
 
 
 
 
 
 
  
 
evaluation of maternal autonomy. 
The primary outcome measure of the study was the post-operative mean pain score (PMPS).
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PPMS = (VAS H0+ VAS H6 + VAS H12+ VAS H18 + VAS H24)/5.
 
Secondary Outcome Measures were: 
-
VAS max : defined as the highest post operative pain score felt during the first day. 
-
Total dose of administrated analgesics during the first 24 hours (mg). 

-
Calculated estimation of blood loss (cEBL): derived by multiplying the calculated
 
 
 
 
 
 
 
 
 
 
 
maternal blood volume by the percent of blood volume lost, were the maternal blood
 
 
 
 
 
 
 
 
 
 
 
 
 
 
volume was calculated by Nadler’s formula based on the patient’s weight, and height.
 
 
 
 
 
 
 
 
 
 
 
 
 
The percent of blood volume lost was calculated with Brecher's formula​⁹ [{predelivery
 
 
 
 
 
 
 
 
 
 
 
 
hematocrit (HCT) – post delivery HCT}/predelivery HCT)]. 
-
Surgery time in minutes: T1: Delay between skin incision and hysterotomy; T2: Delay
 
 
 
 
 
 
 
 
 
 
 
 
 
between hysterotomy and fetal extraction (min); T3: time spent for uterine sutures;
 
 
 
 
 
 
 
 
 
 
 
 
T4: total duration of the surgery. 
-
Rate of short-term incidents: hemorrhage, transfusion, bladder injury or any other
 
 
 
 
 
 
 
 
 
 
 
complication. 
-
Maternal autonomy: time to first spontaneous urination, time to first standing; time
 
 
 
 
 
 
 
 
 
 
 
 
to first complete meal. 
-
Newborn overall condition: Neonatal acid base balance (Cord blood gases, pH and
 
 
 
 
 
 
 
 
 
 
 
 
eucapnic pH¹​⁰​; Apgar score at 1 and 5 minutes after birth, rate of neonate
 
 
 
 
 
 
 
 
 
 
 
 
 
 
hospitalization. 
-
Delay to hospital discharge (days). 
Statistics  
The sample size (N) calculations were based on the post-operative mean pain score
 
 
 
 
 
 
 
 
 
 
 
 
 
(PMPS) as the main outcome measure. The mean (m​1​) and standard deviation (σ) for the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PPMS in the MLC group were estimated by reviewing the records of 80 consecutive women
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
who underwent this procedure in 2017.These values were approximately m1=3,8; σ=2. We
 
 
 
 
 
 
 
 
 
 
 
 
aimed to detect a decrease of 60% in the PMPS in the FAUCS group (m​2​), taking into
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
account the level of significance (p=.05) and the expected power of the study (80%), with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
α=0.05 and β=0.10; we used the following formula: N = M / D​s​
2 ;​M = 2 * (z​1-α + z​1-β​)=17.1;
 
 
 
 
 
 
 
   
  
 
    
  
 
D​s ​= (m​1 – m​2 )/ σ; N= 17.1/ ( 0.6 m1/σ)​2.​. 45 patients per group were required to detect a
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  

decrease of 60% in PMPS scores between the two groups. Ultimately, we recruited 50
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants for each group to account for possible losses. 
We measured 44 outcome variables. The metrics were grouped into four categories:
 
 
 
 
 
 
 
 
 
 
 
 
surgery, overall morbidity, neonatal outcomes and maternal autonomy during recovery. All
 
 
 
 
 
 
 
 
 
 
 
the analyses were conducted in RStudio (version 3.5.1). We performed unequal variance
 
 
 
 
 
 
 
 
 
 
 
 
t-tests for all continuous variables and evaluated each distribution for normality using the
 
 
 
 
 
 
 
 
 
 
 
 
 
Shapiro Wilk test. Continuous variables were analyzed with the student's t test and
 
 
 
 
 
 
 
 
 
  
 
 
Mann-Whitney test. We performed asymptotic generalized Pearson’s chi-squared tests for the
 
 
 
 
 
 
 
 
 
 
 
categorical
variables.
When
the
categorical
variables
were
ordinal,
we
used
the
 
 
 
 
 
 
 
 
 
 
 
Cochran-Armitage test, comparing one ordinal variable with a dichotomous one. All tests
 
 
 
 
 
 
  
 
 
 
 
were performed as 2-tailed tests, and p<.05 was accepted as statistically significant. 
To visualize the results, we employed smoothed kernel density plots of continuous outcome
 
 
 
 
 
 
 
 
 
 
 
 
 
variables for FAUCS compared with the MLC values, which were viewed on a log scale where
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
applicable. 
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