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Table 1 Schedule of enrolment, interventions and assessments

From: Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial

 

STUDY PERIOD

Procedures

Enrolment

Allocation

Post-allocation

24 h after birth

Data taken from case notes after discharge

ENROLLMENT

Assessment of eligibility criteria

X

X

  

Signed consent form

X

   

Randomisation

 

X

  

INTERVENTIONS

Administration of study intervention (misoprostol or oxytocin for augmentation)

 

X

  

ASSESSMENTS

Caesarean Birth

 

X

  

Maternal complications

 

X

X

X

Fetal / neonatal complications

 

X

X

X

Serious maternal complications

 

X

X

X

Cost effectiveness

   

X

Efficacy of induction process

  

X

 

Assessment of adverse events

  

X

X

Mother Generated Index

X

 

X

 

Participant Satisfaction Questionnaire

  

X