Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction (SATISFACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075630
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories :

  • Maternal satisfaction depends on the number of labour-inducing sequences
  • A longer labour-induction would be experienced less positively than a shorter one
  • The experience is correlated with maternal outcomes ( vaginal / Caesarian delivery, spontaneous birth or instrument-assisted birth, maternal complications ) and neonatal outcomes (neonatal complications, secondary hospitalization).

Condition or disease
Labor Induction

Detailed Description:

Artificial labour induction is a medical intervention used in the interest of the mother or unborn child, aimed at provoking birth by inducing uterine contractions artificially, leading to cervical effacement and dilation. The purpose is to end the pregnancy in the interest of the mother and/or foetus.

According to the latest results of the Perinatal Enquiry (2016), induced labour rates total around 22% of pregnancies (767.000 births in 2017) in all maternity clinics. For the university hospitals of Nimes and Montpellier, with Level 3 maternity units (thus requiring a higher rate of inductions), this represents 515 and 550 pregnancies respectively (2017 figures).

There are several methods of inducing labour: use of a cervical ripening balloon (a medical device with which the onset of labour is provoked mechanically), vaginal inserts containing prostaglandins or intravenous perfusion with oxytocin combined with water-breakage. These labour-induction methods may be used alone or in succession depending on the evaluation of the cervix using the Bishop score as a reference. Each method has its own benefits and risks.

There is variability between establishments in the protocols used for cervical ripening.

The Nimes and Montpellier centres both use the same methods, but with different sequences.

Studies are mainly devoted to evaluating each method individually in terms childbirth by vaginal delivery and duration of labour.

Maternal satisfaction, which is a rarely studied multifactorial evaluation, is correlated with women's psychological outcome. A bad experience during childbirth appears to increase the risk of post-partum (PP) psychological disorders.

Considering the current literature available, although there have been trials comparing two isolated labour-induction methods, like the study by Probaat (Jozwiak et al., 2013), which compared obstetrical and neonatal outcomes with the cervical ripening balloon and the prostaglandin insert, none of these studies investigated their impact on maternal satisfaction. Although there have been a few studies evaluating maternal satisfaction at childbirth, there have not been any evaluating satisfaction during artificial labour-induction in a pragmatic situation.

The aim of our study was therefore to evaluate the impact on semi-immediate maternal satisfaction under pragmatic, real-life conditions depending on the various possible induction scenarios (both in terms of the number of methods used, from 1 to 3, and the possible combinations when at least 2 or more methods were used ).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022



Primary Outcome Measures :
  1. Overall patient satisfaction [ Time Frame: 2 hours after giving birth ]
    Overall patient satisfaction evaluated via a 4-point Likert scale (1= not satisfied, 2 = moderately satisfied, 3 = satisfied, 4 = very satisfied) on a touchscreen.


Secondary Outcome Measures :
  1. Patient satisfaction evaluated via the W-DEQ questionnaire [ Time Frame: 2 hours after giving birth ]
    The Wijma Delivery Experience Questionnaire (W-DEQ) is a Scandinavian questionnaire (designed by Wijma et al. in 1998) translated into French. It evaluates the patient's true experience of childbirth compared with her expectations. It has 33 items based on recurring fears of pregnant women, divided into several catégories (fear, negative feelings, lack of confidence, behaviour etc…).

  2. Post-partum QEVA satisfaction questionnaire [ Time Frame: 1-2 months after giving birth ]
    The pluridimensional Questionnaire d'Evaluation du Vécu de l'Accouchement (QEVA) known in English as the QACE (Questionnaire for Assessing the Childbirth Experience is used to evaluate the patient's experience of childbirth. It contains 25 items, each with a 4-point Likert scale, divided into the following categories: relationship with healthcare teams, emotions (positive and negative), first moments with the newborn baby, situation one month after childbirth. An e-mail is sent to the patient 1 month after giving birth, asking her to complete the QEVA by logging onto a dedicated platform.

  3. Different methods of labour-induction used [ Time Frame: 6 months after giving birth ]
    Data collection from medical files on the methods of labour-induction used (alone or successively), duration of use and intermediate Bishop scores. This a pre-labor scoring system reflecting cervical modification ranges from 0 to 3 (0= cervix closed and 3 = dilated to more than 5 cm) assists in predicting whether labour-induction will be required and the likelihood of spontaneous preterm delivery.

  4. Spontaneous vaginal deliveries [ Time Frame: 48 hours maximum ]
    Rate of spontaneous vaginal deliveries,

  5. Rate of instrument-assisted vaginal deliveries [ Time Frame: 48 hours maximum ]
    Rate of instrument-assisted vaginal deliveries.

  6. Reason for instrument-assisted vaginal deliveries [ Time Frame: 48 hours maximum ]
    Reason for instrument-assisted vaginal deliveries (non progression of fœtal presentation, fœtal distress, maternal complications).

  7. Type of instrument-assisted vaginal deliveries [ Time Frame: 48 hours maximum ]

    Type of instrumental extraction used for the delivery

    .


  8. Rate of Caesarian births [ Time Frame: 48 hours maximum ]
    Rate of Caesarian births and reason (no cervical dilatation at the first stage of labour : dilatation 0 to 10cm, absence of fœtal descent at stage 2 of labour, fœtal cause, maternal cause).

  9. Reason for Caesarian births [ Time Frame: 48 hours maximum ]
    Reason for Caesarian birth (no cervical dilatation at the first stage of labour : dilatation 0 to 10cm, absence of fœtal descent at stage 2 of labour, fœtal cause, maternal cause).

  10. Time from start of labour-induction to start of labour [ Time Frame: 48 hours maximum ]
    Time between the start of labour-induction and the onset of labour will be measured

  11. Time from labour-induction to birth (Caesarian births excluded), [ Time Frame: 48 hours maximum ]
    Time from labour-induction to vaginal delivery

  12. Vaginal deliveries at H12 [ Time Frame: 12 hours from start of induction ]
    Rate of vaginal deliveries at 12 hours from start of labour-induction

  13. Vaginal deliveries at H24 [ Time Frame: 24 hours from start of induction ]
    Rate of vaginal deliveries at 24 hours from start of labour-induction

  14. Vaginal deliveries at H48 [ Time Frame: 48 hours from start of induction ]
    Rate of vaginal deliveries at 48 hours from start of labour-induction

  15. Labour-induction failures [ Time Frame: 12 - 18 hours ]
    Rate of labour-induction failures giving rise to a Caesarian due to the duration of the latency phase (0-6cm) ≥24h with oxytocine administered for at least 12-18h after artificial water-breakage.

  16. Propess [ Time Frame: up to 48 hours before birth ]
    Rate of secondary or tertiary use of Propess (vaginal prostaglandine inserts)

  17. Balloon/Foley bulb [ Time Frame: 48 hours maximum ]
    Rate of secondary or tertiary use of the cervical ripening balloon (Foley bulb)

  18. Oxytocine [ Time Frame: 48 hours maximum ]
    Rate of secondary or tertiary use of intravenous Oxytocine

  19. Epidurals [ Time Frame: 48 hours maximum ]
    Rate of epidural anesthaesia during labour

  20. Bishop score evolution: Propess [ Time Frame: Until birth (48 hours maximum) ]
    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

  21. Bishop score evolution: Balloon/Foley bulb [ Time Frame: Until birth (48 hours maximum) ]
    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

  22. Bishop score evolution: Ocytocine [ Time Frame: Until birth (48 hours maximum) ]
    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

  23. Maternal morbidity [ Time Frame: 6 months after giving birth ]
    Rate of uterine hyperstimulation(> 6 contractions in 10 minutes on 2 occasions) with or without an effect on the foetus

  24. Maternal morbidity [ Time Frame: 48 hours maximum ]
    Rate of uterine hypertonia (contraction > 2 minutes with slowing down of fœtal heartbeat)

  25. Maternal morbidity: moderate haemorrhage [ Time Frame: 48 hours maximum ]
    Rate of post partum haemorrage ≥ 500ml, rate of severe post-partum haemorrhage ≥1000ml, rate of transfusion, number of packs of red blood cells transfused

  26. Maternal morbidity: severe haemorrage [ Time Frame: 48 hours maximum ]
    rate of severe post-partum haemorrage ≥1000ml rate of transfusion, number of packs of red blood cells transfused

  27. Maternal morbidity: transfusion rate [ Time Frame: 48 hours maximum ]
    Rate of transfusions

  28. Maternal morbidity: amount of blood transfused [ Time Frame: 48 hours maximum ]
    This is measured in terms of the number of packs of red blood cells transfused

  29. Maternal morbidity: rupture [ Time Frame: 48 hours maximum ]
    Rate of uterine rupture

  30. Maternal morbidity: Chorioamniotitis [ Time Frame: 48 hours maximum ]
    Chorioamniotitis (temperature > 38°C with fœtal tachycardia > 160 beats / minute)

  31. Maternal morbidity: infection [ Time Frame: 1 week after giving birth ]
    Rate of post-partum infection (temperature > 38°C with antibiotherapy, urinary infection, bacteriologically-proven endometritis at 1 week post-partum)

  32. Neonatal morbidity:asphyxia [ Time Frame: 5 minutes after giving birth ]
    Rate of neonatal asphyxia (umbilical cord arterial pH ≤ 7.05, and/or APGAR at 5 minutes < 7). The Apgar score is a means of evaluating the vitality of a newborn based on the simple observation at the time of birth. The value is a prognostic for neonatal mortality. It was developed in 1952 by the American doctor, Virginia Apgar.

  33. Neonatal morbidity: neonatal hospitalisation [ Time Frame: up to 48 hours after giving birth ]
    Rate of neonatal pediatric hospitalisations

  34. Neonatal morbidity: infection [ Time Frame: up to 48 hours after giving birth ]
    Bacteriologically-proven infection rate

  35. Maternal tolerance: bleeding [ Time Frame: up to 48 hours after giving birth ]
    Metrorrhagia due to vaginal insert (dinoprostone) or cervical ripening balloon placement

  36. Maternal tolerance: pain due to overinflation of the balloon (Foley bulb) [ Time Frame: up to 48 hours after giving birth ]
    Pain related to balloon inflation requiring secondary partial deflation, reorded with a VAS. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

  37. Maternal tolerance: pain on 1st induction sequence [ Time Frame: up to 48 hours before birth ]
    Pain level recorded with a VAS before the 1st induction sequence. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

  38. Maternal tolerance: pain after childbirth [ Time Frame: 2 hours after giving birth ]
    Pain level recorded with a VAS at H2 of childbirth.

  39. Maternal tolerance: pain during childbirth [ Time Frame: labour time ]
    Pain level at various times of labour-induction recorded with a VASThe visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

  40. Maternal tolerance: pain due to insert or balloon (Foley bulb) [ Time Frame: up to 48 hours before birth ]
    Pain level recorded with a VAS before vaginal insert or balloon placement. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

  41. Maternal tolerance: pain due to insert or balloon (Foley bulb) at H2 [ Time Frame: 2 hours after device placement ]
    Pain level recorded with a VAS 2 hours after vaginal insert or balloon placement. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women at the end of pregnancy
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women 18+ admitted to gynecology-obstetric depts. of Montpellier & Nîmes University Hospitals for artificial labor-induced childbirth. Sociodemographic and medical variables will be noted: patient's knowledge of labor-induction, labor in childbirth, age, weight, height (BMI), no. of previous pregnancies, childbirths, miscarriages, abortions, medically-motivated induced terminations, medical antecedents (comorbidities), important surgery (esp. uterine), ongoing treatment, tobacco/alcohol/cannabis intake, Down's syndrome screening, pregnancy particularities (medically-assisted procreation), antenatal diagnosis, no. of hospital consultations, gestational age at admission, information received, other newborn data (term, weight, size, cranial perimeter at birth), reason for induction.
Criteria

Inclusion Criteria:

The patient has made no formal opposition to taking part in the study.

  • The patient must be affiliated to/have the benefit of a health insurance scheme.
  • The patient is at least 18 years old.
  • The patient is capable of understanding the instructions required for answering questionnaires in French.

Concerning the targeted population:

  • The patient has a medical indication for labour-induction.
  • Term ≥ 37 weeks.
  • The foetus is alive and viable, without any known lethal pathology

Exclusion Criteria:

The person is in a period of exclusion determined by a previous study.

  • The person has been placed under judicial protection and is under guardianship or curatorship.
  • It is impossible to give the person accurate information.

Non-inclusion criteria concern associated illnesses or interfering conditions:

  • The patient does not have the possibility to answer the questionnaire at 1 month
  • Contra-indication for labour-induction or vaginal delivery
  • Foetal presentation other than cephalic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075630


Contacts
Layout table for location contacts
Contact: Benjamin COPPEL, M. 06 82 75 67 40 benjamin.coppel@chu-nimes.fr

Locations
Layout table for location information
France
Centre Hospitalier Universitaire Recruiting
Nîmes, Gard, France, 30029
Contact: Hélène MARTIN    06 50 58 64 11    helene.martin@chu-nimes.fr   
Sub-Investigator: Vincent LETOUZEY, Pr         
Sub-Investigator: Renaud De TAYRAC, Pr         
CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique Not yet recruiting
Montpellier, Hérault, France, 34090
Contact: Florent FUCHS, Dr.    04 66 68 31 49    f-fuchs@chu-montpellier.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Benjamin COPPEL, M. CHU de Nîmes Service de Gynécologie Obstétrique
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04075630    
Other Study ID Numbers: NIMAO/2018-03/BC-01
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
childbirth
oxytocin
prostaglandin
cervical ripening balloon