Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05885087 |
| Other study ID # |
UBR/RES/IRB/BIO/GRAD/145 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Botswana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overall aim of the single arm pilot study was to assess the effectiveness, safety and
acceptance of the 'extended balloon catheter' as a method of induction of labour in women
receiving care at Princess Marina Hospital(PMH) in Gaborone, Botswana.
The main questions it aimed to answer were whether 'extended balloon catheter' is an
effective method of labour induction, whether it results in increased adverse events for the
mother and baby and whether it is associated with increased mother satisfaction.
Participants were assessed as having a favourable cervix using the modified Bishop score of
equal to or more than 7. Three Foley balloon catheters attached side by side were inflated
with 60mls each and a gentle traction of 250mls water applied. Delivery interval (time of
induction to time of delivery), mode of delivery and Apgar scores were recorded. Adverse
maternal and neonatal outcomes were recorded. Participants' satisfaction with the method of
induction was assessed using a descriptive scale.
Description:
Labour induction is indicated when the benefits to the mother and/or foetus of discontinuing
the pregnancy outweigh the risks of awaiting spontaneous onset of labour. However, induction
of labour is not without risk and the World Health Organisation recommends induction of
labour be performed with a clear medical indication and when the expected benefits outweigh
potential harms. Established indications for induction of labour include gestational age of
41 completed weeks or more, prelabour rupture of amniotic membranes, hypertensive disorders,
maternal medical complications, foetal growth restriction, chorioamnionitis, multiple
pregnancy, vaginal bleeding and other complications.
The ideal method for induction should be safe for both the mother and baby, cost effective
and not require extensive monitoring. Trans-cervical extra-amniotic Foley catheter placement
has been shown to be the safest method of labour induction with fewer maternal and neonatal
side effects such as uterine hyperstimulation and changes in foetal heart rate during labour
than prostaglandins or oxytocin. It has also been shown that there were no significant
differences between caesarean and vaginal deliveries between Foley catheter, prostaglandins
and oxytocin, although labour was shown to last longer after induction with Foley catheter
than with prostaglandins and oxytocin. These factors can therefore potentially influence the
women's preference for either method.
Foley catheter has generally been used for labour induction with an unfavourable cervix and
once the cervix is favourable or the Foley method is unsuccessful, prostaglandins or oxytocin
with amniotomy are used. In lower and middle income countries like Botswana where patient
monitoring during induction of labour and labour is limited and mostly intermittent, mainly
due to the limited or lack of monitoring devices to detect uterine hyperstimulation or foetal
heart rate changes, a high patient to midwife ratio, and a high HIV prevalence, it may be
preferable to avoid amniotomy and risks associated with hyperstimulation with exogenous
oxytocin or prostaglandins. There are no randomized trials of Foley catheter induction with a
favourable cervix reported in the Cochrane review of mechanical methods of labour induction.
To optimize the likelihood of delivery without recourse to amniotomy and oxytocin or
prostaglandins, 'extended balloon catheter' has been proposed as a method of continuing
induction and augmentation with a Foley catheter rather than switching to other methods.
The purpose of this proposed single arm pilot trial was to test this novel idea of using
'extended balloon catheter' for induction of labour in women with favourable cervix in
Botswana, and assess its effectiveness, safety to both the mother and baby as well as patient
satisfaction with the procedure. Findings from this study will guide clinical protocols on
how to utilize the safest available option for optimal maternal and neonatal outcomes as well
as offer options and evidence for counselling women for whom prostaglandins or oxytocin are
contraindicated or for use with caution in Botswana and elsewhere.
