Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308714803965 Date of Approval: 07/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Active management of labor versus expectant management in first nulliparas with a prolonged latent phase: a randomized trial
Official scientific title Active management of labor versus expectant management in first nulliparas with a prolonged latent phase: a randomized trial
Brief summary describing the background and objectives of the trial Normal childbirth begins spontaneously and has only a small risk identified at the start of labor. The fetus was born spontaneously in the upright position at 37 to 42 weeks gestation. Normal delivery is confirmed by the normal vital parameters of the newborn and the immediate puerperium for the mother. The length of the latent phase varies from woman to woman and can be as long as 8 p.m. By definition According to the WHO, a prolonged latency phase is the absence of cervical dilation beyond four centimeters after eight hours of regular CU. In this situation, women who are leaving would be more exposed to medical interventions with a higher rate of emergency Cesarean section. There is no consensus regarding the management of these patients. Thus, two attitudes are possible: expectant management, allowing labor to proceed spontaneously, and active management, with amniotomy and oxytocin infusion. In this context, this study was performed to compare the two groups, active management (amnitomia and oxytocin infusion) and expectancy management according to:  The primary endpoint: the rate of cesarean delivery.  Secondary endpoints: · Immediate postpartum maternal complications. · Neonatal outcomes. · The total duration of the work and its various phases. · Satisfaction and well-being of female participants on the Likert scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied other
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 340
Actual target sample size (number of participants) 340
Recruitment status Completed
Publication URL bardaaoussema@hotmail.fr
Secondary Ids Issuing authority/Trial register
0371 2021 COMITE ethique DE PROTECTION DES PERSONNES SUD
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group amniotomy and oxytocin infusion The initial dose administered was 4 mIU per minute, while increasing the dose by 2 mIU every 20 minutes (not to exceed 30 mIU/min) 24 hours The procedure was defined as artificial rupture of the membranes with infusion of oxytocin. The initial dose administered was 4 mIU per minute, while increasing the dose by 2 mIU every 20 minutes (not to exceed 30 mIU/min), until a satisfactory contractile regime (i.e. 3 to 5 uterine contractions per 10 minutes) was achieved. 170
Control Group expectative no oxytocin 24 hours no amnitomy or oxytocin infusion, labor is allowed to progress spontaneously 170 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Spontaneous entry into labor.  A prolonged latent phase of labor (absence of cervical dilation beyond four centimeters after eight hours of regular uterine contractions (UC)).  nulliparous (No previous pregnancy > 20 weeks).  PFE between 2000 gram(g) and 4000g.  The presence of CUs (at least 1 CU/30 min).  Cervical dilation ≤ 3 cm.  Pocket of water (PDEA) intact.  First trimester ultrasonography done.  Pregnancy term (TG): ≥ 37SA.  A single, progressive pregnancy.  Summit presentation.  A good bony pelvis.  Normal oscillating, normal reactive fetal heart rhythm recording (ERCF).  Bishop score ≥ 6.  Estimated fetal weight ≥ 4000 g or ≤ 2000 g.  Induction of labor  Contraindications to vaginal delivery.  Scar womb (history of uterine surgery).  Presence of a history of significant disease vs. direction of labor.  Multiparity.  TG < 37 SA.  Bishop score < 6.  Presentation other than summit.  Pathological ERCF.  Unexplained placenta previa or metrorrhagia. Adult: 19 Year-44 Year 16 Year(s) 38 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/12/2021 MINISTRY OF HEALTH PERSONAL PROTECTION COMMITTEE SOUTH
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur de Tunis , 1002 TUNIS BELVEDERE sfax 3013 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The rate of cesarean section was 35.6% in the overall population, including 27.6% in the expectant management group versus 43.5% in the active management group; p<0.001. The rate of forceps delivery was 4.7% for the Expectative Management Group versus 10% for the Active Management Group; p<0.001 The rate of vaginal delivery without forceps was 67.6% for the Expectative Management Group versus 46.5% for the Active Management Group; p<0.001 6 mois
Secondary Outcome For secondary endpoints, immediate maternal complications were noted in 36 cases. They were more common in the Active Management Group with significant difference. The most common maternal complication was postpartum hemorrhage (PPH) and it was most common in the Active Management Group with significant difference between the two groups. The rate of late postpartum complications was similar in both groups. And the mean length of hospitalization was 38 hours, it was greater in the Active Management Group with a significant difference. Neonatally, for the apgar score at the first minute, 93.5% of neonates in the expectation management group were well adapted to extrauterine life with apgar score > 8 versus 84.7 in the active management group, with a significant difference between the two groups. By the 5th minute, the apgar score had improved for the entire population. Resuscitation procedures were required in 10% of cases and hospitalization in the neonatology department in 6% of cases. They were significantly more frequent in the Active Management Group. Similarly, complications dominated by acute respiratory distress were higher for this group. For the duration of labor, the average time between surgery and vaginal delivery was 15 h and 47 min for the expectation group and 8 h and 26 min for the active group. With significant difference, (p=0.001). The mean duration of the latency phase was 20 h and 38 min for the Expectative Management Group and 13 Het 19 min for the Active Management Group with a very significant difference (p<0.001). 6 mois
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gynecology and obstetrics department hedi chaker sfax street ain km0.5 sfax, Tunis sfax 3013 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
hedi cheker hospital street ain km0.5 sfax 3013 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hedi cheker hospital route ain km 0.5 sfax 3031 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator oussema bardaa bardaaoussema@hotmail.fr +21652430325 street afran km3 sfax
City Postal code Country Position/Affiliation
sfax 3013 Tunisia resident
Role Name Email Phone Street address
Public Enquiries oussema bardaa bardaaoussema@gmail.fr +21652430325 street afran km3
City Postal code Country Position/Affiliation
sfax 3013 Tunisia resident
Role Name Email Phone Street address
Scientific Enquiries jihen jedidi jdiditrabelsijihen@gmail.com +21651061561 street afran km 5
City Postal code Country Position/Affiliation
sfax 3012 Tunisia professeur
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code Informed Consent Form,Study Protocol 12 month contoroled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
bardaaoussema@hotmail.fr Yes 03/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/08/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information