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Completed

NCT Number: NCT04342741

Inpatient and Outpatient Balloon Catheter Cervical Ripening

A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

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Key information

Conditions

Caesarean Section; Infection Behavior Health Behavior Infections Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton
  • gestational age beyond 37 weeks
  • cephalic presentation
  • intact membranes
  • Bishop score less than 6
  • lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes
  • readily available transport

Exclusion criteria

  • intrauterine death
  • intrauterine fetal growth restriction
  • estimated fetal weight more than 4000gram
  • fetal anomalies
  • abnormal pre-induction cardiotocograph
  • non-vertex presentation
  • unstable lie
  • sepsis
  • hypertension
  • allergy to latex
  • previous uterine scar
  • history of antepartum haemorrhage
  • parity of 6 and more
  • placenta praevia
  • suspected cephalopelvic disproportion

Treatment and study plan

Foley catheter cervical ripening

Device

Participants were assessed when labour was established or the following morning.

Primary outcomes

  1. Caesarean section rate

    Time frame: From the time of recruitment until delivery

    Percentage of Caesarean section

  2. Neonatal sepsis

    Time frame: From birth up to 30 days

    Percentage of neonates with sepsis

Secondary outcomes

  1. Maternal age

    Time frame: At the time of recruitment

    Mean maternal age in years

  2. Ethnicity

    Time frame: At the time of recruitment

    Percentage of each races

  3. Education level

    Time frame: At the time of recruitment

    Percentage of participants with secondary or higher education level

  4. Occupation

    Time frame: At the time of recruitment

    Percentage of participants who were professional or non professional or housewives

  5. Pre-pregnancy maternal body mass index

    Time frame: At the time of recruitment

    Mean pre-pregnancy body mass index in kg/m2

  6. Parity

    Time frame: At the time of recruitment

    Percentage of participants who are nulliparous or multiparous

  7. Gestation at recruitment

    Time frame: At the time of recruitment

    Percentage of participants who were recruited at 40 or 40 weeks and 10 days

  8. Indication

    Time frame: At the time of recruitment

    Percentage of participants who were induced based on indication

  9. Bishop score pre-induction

    Time frame: Pre-intervention

    Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5.

  10. Bishop score at second assessment

    Time frame: From insertion of Foley catheter until labour established or the following morning

    Mean Bishop score at second assessment. Unfavourable score has minimum score of 0 and maximum score of 5.

  11. Management at second assessment

    Time frame: At time of recruitment until delivery

    Percentage of participants who had dinoprostone insertion or artificial rupture of membranes

  12. Duration from induction until favourable Bishop score

    Time frame: At time of recruitment until delivery

    Mean duration taken from induction until favourable Bishop score in hours

  13. Augmentation with oxytocin

    Time frame: At time of recruitment until delivery

    Percentage of participants who required oxytocin augmentation

  14. Duration of oxytocin use

    Time frame: At time of recruitment until delivery

    Mean duration of oxytocin use in minutes

  15. Duration from amniotomy until delivery

    Time frame: At time of recruitment until delivery

    Mean duration from amniotomy until delivery in hours

  16. Duration from induction until delivery

    Time frame: At time of recruitment until delivery

    Mean duration from induction until delivery in hours

  17. Delivery within 24 hours

    Time frame: At time of recruitment until delivery

    Percentage of participants who delivered within 24 hours from induction

  18. Duration of inpatient stay

    Time frame: At time of recruitment until delivery

    Mean duration of inpatient stay in hours

  19. Total blood loss

    Time frame: At the time of delivery

    Median blood loss in millilitres

  20. Intrapartum pyrexia

    Time frame: At the time of delivery

    Percentage of participants with intrapartum pyrexia

  21. Primary postpartum haemorrhage

    Time frame: Immediately at delivery up to 42 days

    Percentage of participants with primary postpartum haemorrhage

  22. Birth weight

    Time frame: At the time of delivery

    Mean birth weight in grams

  23. Arterial cord blood acidity or alkalinity

    Time frame: At the time of delivery

    Mean arterial cord blood acidity or alkalinity

  24. Neonatal white cell count

    Time frame: At the time of delivery

    Mean neonatal white cell count in liter

  25. Neonatal C-reactive protein

    Time frame: At the time of delivery

    Median neonatal C-reactive protein in milligram per liter

  26. Discomfort with foley catheter

    Time frame: At the time of recruitment until active phase of labour

    Percentage of participants experienced discomfort with foley catheter

  27. Ability to cope with discomfort

    Time frame: At the time of recruitment until active phase of labour

    Percentage of participants able to cope with discomfort

  28. Intention to use the method again

    Time frame: Through study completion until delivery

    Percentage of participants who intend to use similar method in future

  29. Feeling alone during induction

    Time frame: At the time of recruitment until delivery

    Percentage of participants who felt lonely during induction

  30. Duration of sleep

    Time frame: At the time of recruitment until delivery

    Duration of sleep during induction in hours

  31. Able to rest and relax

    Time frame: At the time of recruitment until delivery

    Percentage of participants who are able to rest and relax

  32. Feeling of unsafe during cervical ripening

    Time frame: At the time of recruitment until active phase of labour

    Percentage of participants who felt unsafe during cervical ripening

  33. Embarrassed by the method

    Time frame: At the time of recruitment until active phase of labour

    Percentage of participants who felt embarrassed by the method

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2020
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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