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Clinical Trial Summary

Prospective quasi-experimental study between a study population who will receive outpatient induction of labour using intracervical Foley catheter, followed by the inpatient induction using intravaginal prostaglandin and a control group of women with similar characteristics undergoing inpatient labour induction with intravaginal prostaglandin (standard management)


Clinical Trial Description

The study will be conducted among pregnant women in 2 to 5th pregnancy who have no significant risk factors and planned for induction of labour. The eliiable women will be recruited from 4 health clinics within the district (of Kemaman, Malaysia) and located within 20 km from the hospital. Willing participants will be seen in the hospital at the planned induction date and reassessed. Should they be suitable for induction of labour using Foley catheter on outpatient basis, a 18G Foley catheter will be inserted into the cervical canal and the balloon inflated with sterile water (60 mls). The fetal well being will be assessed and the women allowed to go home with instruction related to the induction and the study. Those who do not enter the active phase of labour will be admitted to the ward 24 hours later and will undergo inpatient induction of labour using intravaginal prostaglandin (Dinoprostone) according to the local protocol. These women will be compared with a control group comprising of women with similar characteristics and undergo inpatient induction of labour with intravaginal Dinoprostone. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05622968
Study type Interventional
Source Hospital Kemaman
Contact Zahar Zakaria, MD
Phone 6098513333
Email zazuarz@yahoo.co.uk
Status Not yet recruiting
Phase N/A
Start date January 1, 2023
Completion date June 30, 2024

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