Inpatient and Outpatient Balloon Catheter Cervical Ripening

• Sponsor: National University of Malaysia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04342741
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Caesarean Section; Infection	Device: Foley catheter cervical ripening	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Foley catheter inpatient Participants had intracervical ripening with foley catheter after admission into the ward.	Device: Foley catheter cervical ripening; Participants were assessed when labour was established or the following morning.
Active Comparator: Foley catheter outpatient Participants had intracervical ripening with foley catheter and allowed home.	Device: Foley catheter cervical ripening; Participants were assessed when labour was established or the following morning.

Outcome Measures

Primary Outcome Measures

1. Caesarean section rate [From the time of recruitment until delivery]

   Percentage of Caesarean section

2. Neonatal sepsis [From birth up to 30 days]

   Percentage of neonates with sepsis

Secondary Outcome Measures

1. Maternal age [At the time of recruitment]

   Mean maternal age in years

2. Ethnicity [At the time of recruitment]

   Percentage of each races

3. Education level [At the time of recruitment]

   Percentage of participants with secondary or higher education level

4. Occupation [At the time of recruitment]

   Percentage of participants who were professional or non professional or housewives

5. Pre-pregnancy maternal body mass index [At the time of recruitment]

   Mean pre-pregnancy body mass index in kg/m2

6. Parity [At the time of recruitment]

   Percentage of participants who are nulliparous or multiparous

7. Gestation at recruitment [At the time of recruitment]

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

8. Indication [At the time of recruitment]

   Percentage of participants who were induced based on indication

9. Bishop score pre-induction [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 [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 [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 [At time of recruitment until delivery]

    Mean duration taken from induction until favourable Bishop score in hours

13. Augmentation with oxytocin [At time of recruitment until delivery]

    Percentage of participants who required oxytocin augmentation

14. Duration of oxytocin use [At time of recruitment until delivery]

    Mean duration of oxytocin use in minutes

15. Duration from amniotomy until delivery [At time of recruitment until delivery]

    Mean duration from amniotomy until delivery in hours

16. Duration from induction until delivery [At time of recruitment until delivery]

    Mean duration from induction until delivery in hours

17. Delivery within 24 hours [At time of recruitment until delivery]

    Percentage of participants who delivered within 24 hours from induction

18. Duration of inpatient stay [At time of recruitment until delivery]

    Mean duration of inpatient stay in hours

19. Total blood loss [At the time of delivery]

    Median blood loss in millilitres

20. Intrapartum pyrexia [At the time of delivery]

    Percentage of participants with intrapartum pyrexia

21. Primary postpartum haemorrhage [Immediately at delivery up to 42 days]

    Percentage of participants with primary postpartum haemorrhage

22. Birth weight [At the time of delivery]

    Mean birth weight in grams

23. Arterial cord blood acidity or alkalinity [At the time of delivery]

    Mean arterial cord blood acidity or alkalinity

24. Neonatal white cell count [At the time of delivery]

    Mean neonatal white cell count in liter

25. Neonatal C-reactive protein [At the time of delivery]

    Median neonatal C-reactive protein in milligram per liter

26. Discomfort with foley catheter [At the time of recruitment until active phase of labour]

    Percentage of participants experienced discomfort with foley catheter

27. Ability to cope with discomfort [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 [Through study completion until delivery]

    Percentage of participants who intend to use similar method in future

29. Feeling alone during induction [At the time of recruitment until delivery]

    Percentage of participants who felt lonely during induction

30. Duration of sleep [At the time of recruitment until delivery]

    Duration of sleep during induction in hours

31. Able to rest and relax [At the time of recruitment until delivery]

    Percentage of participants who are able to rest and relax

32. Feeling of unsafe during cervical ripening [At the time of recruitment until active phase of labour]

    Percentage of participants who felt unsafe during cervical ripening

33. Embarrassed by the method [At the time of recruitment until active phase of labour]

    Percentage of participants who felt embarrassed by the method

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UKM Medical Centre	Cheras	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

• National University of Malaysia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rahana Abd Rahman, Co-primary investigator, National University of Malaysia
• ClinicalTrials.gov Identifier: NCT04342741
• Other Study ID Numbers: FF-2017-358
• First Posted: Apr 13, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rahana Abd Rahman, Co-primary investigator, National University of Malaysia: cervical ripening; Foley catheter; Patient satisfaction

Study Results

No Results Posted as of Apr 13, 2020