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A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction (MOLI)

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ClinicalTrials.gov Identifier: NCT03749902
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
Gynuity Health Projects
Government Medical College, Nagpur, India
Information provided by (Responsible Party):
Andrew Weeks MD MRCOG, University of Liverpool

Brief 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?

Condition or disease Intervention/treatment Phase
Induction of Labor Drug: Oral misoprostol Drug: Oxytocin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Oral Misoprostol Alone With Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oxytocin infusion
  • 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.
Drug: 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.
Other Name: Pitocin

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.
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.
Other Name: Misoprost




Primary Outcome Measures :
  1. Caesarean birth [ Time Frame: At delivery ]
    Rate of caesarean birth in the treatment arm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749902


Contacts
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Contact: Hillary Bracken 2124481230 hbracken@gynuity.org

Locations
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India
Government Medical College (GMC) Recruiting
Nagpur, India
Contact: Shuchita Mundle, MD       srmundle@gmail.com   
Principal Investigator: Shuchita Mundle, MD         
Sponsors and Collaborators
University of Liverpool
Gynuity Health Projects
Government Medical College, Nagpur, India
Investigators
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Principal Investigator: Andrew D Weeks, FRCOG University of Liverpool
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Responsible Party: Andrew Weeks MD MRCOG, Prof of International Maternal Health, University of Liverpool
ClinicalTrials.gov Identifier: NCT03749902    
Other Study ID Numbers: 4007
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data from this study will be confidential until the database is closed at the end of the study. Following this the study investigators will have exclusive access to the data until the publication of the results in a journal. Once this has happened, the database will be open to other researchers upon request. Open access databases will also be sought so as to maximise the availability of our research data with as few restrictions as possible, in line with MRC and Wellcome Trust policy. The consent form will include a clause for the woman to give permission for her anonymous data to be used for future research studies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be released upon publication of the trial results. After this, the data will be shared on a public database to maximise the viability of the data.
Access Criteria: Initially this will be upon request with later public publication of the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Weeks MD MRCOG, University of Liverpool:
preeclampsia
misoprostol
oxytocin
Additional relevant MeSH terms:
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Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents