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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03749902
Other study ID # 4007
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 6, 2020
Est. completion date July 30, 2022

Study information

Verified date August 2022
Source University of Liverpool
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?


Description:

Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. However, some studies have shown that oral misoprostol can be continued into active labour. In the Cochrane review on labour induction, those whose augmentation was continued with misoprostol (M/M protocol) had 42% less CSs than those who changed to oxytocin (M/Ox protocol; 15% vs 26%). This misoprostol-only protocol would be simpler and probably more acceptable to women. However, these two protocols have never been directly compared. We propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.


Recruitment information / eligibility

Status Completed
Enrollment 520
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - • Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not - Women age =18 years - Signed informed consent form - Undergone cervical ripening with misoprostol if cervix initially unfavourable - Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s Exclusion Criteria: - Women with previous caesarean births - Those unable to give informed consent - Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins) - Multiple pregnancy - History of allergy to misoprostol - Adequate uterine activity - Pre- induction Ruptured amniotic membranes - Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral misoprostol
An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose). The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes) If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency.
Oxytocin
Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics. The oxytocin group will not receive misoprostol after the membranes have ruptured.

Locations

Country Name City State
India Daga Memorial Women's Hospital Nagpur Maharashtra
India Government Medical College (GMC) Nagpur
India Mahatma Gandhi Institute of Medical Sciences Sevagram Maharashtra

Sponsors (5)

Lead Sponsor Collaborator
University of Liverpool Daga Memorial Women's Hospital, Nagpur, India, Government Medical College, Nagpur, Gynuity Health Projects, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caesarean birth Rate of caesarean birth in the treatment arm At delivery
See also
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Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A