Submited on: 29 Feb 2016 04:13:08 PM GMT
Published on: 01 Mar 2016 05:32:17 AM GMT
 

  • What are the main claims of the paper and how important are they?

    Induction of labour is a day to day practice and this article is useful contribution


  • Are these claims novel? If not, please specify papers that weaken the claims to the originality of this one.

    The claims are novel


  • Are the claims properly placed in the context of the previous literature?

    The claims properly placed in the context of the previous literature


  • Do the results support the claims? If not, what other evidence is required?

    Results support the claim


  • If a protocol is provided, for example for a randomized controlled trial, are there any important deviations from it? If so, have the authors explained adequately why the deviations occurred?

    Protocols are followed properly. No deviations from the accepted the standard


  • Is the methodology valid? Does the paper offer enough details of its methodology that its experiments or its analyses could be reproduced?

    Methodology is valid


  • Would any other experiments or additional information improve the paper? How much better would the paper be if this extra work was done, and how difficult would such work be to do, or to provide?

    The information given in the paper is adequate


  • Is this paper outstanding in its discipline? (For example, would you like to see this work presented in a seminar at your hospital or university? Do you feel these results need to be incorporated in your next general lecture on the subject?) If yes, what makes it outstanding? If not, why not?

    This paper is reasonable and can be published


  • Other Comments:

    The paper deserves publication

  • Competing interests:
    .
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    I am a British qualified obstetrician. I had worked as consultant for 20 years and presently I am working as a professor in Obstetrics and gynaecology in Malaysia

  • How to cite:  Najimudeen M M.Induction of labour in women with nonscarred uterus using balloon catheter: Randomised controlled trial [Review of the article 'Induction of labour in women with nonscarred uterus using balloon catheter: Randomised controlled trial ' by Al Hazmi J].WebmedCentral 2016;7(5):WMCRW003288
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  • What are the main claims of the paper and how important are they?

    The authors have published a protocol for an RCT they intend to perform to study efficacy and safety of Foley catheter induction in comparison to prostaglandin vaginal tablet in term pregnant women with nonscarred uterus. This trial will be a single center, open-label, randomized controlled trial. It will be performed in Madinah Maternity and Children Hospital (MMCH) on 500 participants. Group allocation of the patients will be done using simple alternative patient randomization. First patient will receive transcervical Foley catheter induction, while the next will receive 3mg prostaglandin vaginal tablets. Outcome measures will include induction to delivery interval, mode of delivery, maternal morbidity, Apgar score less than 7 at 5 minutes, and fetal admission to NICU.


  • Are these claims novel? If not, please specify papers that weaken the claims to the originality of this one.

    Similar RCTs including Cochrane review have already been published. The authors claim that:

    1. This is the first study or one of the first studies to be conducted in a developing country and in the Middle East to study efficacy and safety of Foley catheter induction in non-scarred uterus in comparison to prostaglandin vaginal tablet.

    2. Most of the previous studies on Foley catheter induction were conducted on patients with previous caesarean section while minimal studies conducted on non-scarred uterus; while this study will include women with non-scarred uterus only.

    Both these claims are partially correct. Regarding second claim: majority of previous studies have excluded scared uterus from the trials.


  • Are the claims properly placed in the context of the previous literature?

    Yes


  • Do the results support the claims? If not, what other evidence is required?

    Not applicable


  • If a protocol is provided, for example for a randomized controlled trial, are there any important deviations from it? If so, have the authors explained adequately why the deviations occurred?

    Not applicable


  • Is the methodology valid? Does the paper offer enough details of its methodology that its experiments or its analyses could be reproduced?

    Yes


  • Would any other experiments or additional information improve the paper? How much better would the paper be if this extra work was done, and how difficult would such work be to do, or to provide?

    The authors may consider following amendments

    One of the inclusion criteria is “unfavourable cervix”. It will be more appropriate to quantify it as Bishop score e.g. a score of ≤5

    Despite authors explanation, alternate assignment of patients to two groups is an inadequate form of randomization and is open to selection bias.1 A proper randomization list should be generated. Moreover, the study population is heterogeneous in the form of both nulliparous and multiparous women. The nulliparous and multiparous patients should be randomized separately.

    Outcome measures should also include cervical changes such as change in Bishop score induced by transcervical Foley catheter and prostaglandin vaginal tablets.

    It is not mentioned how the further labour will be managed after the initial ripening of the cervix with Foley catheter or vaginal prostaglandin. It will probably be left to the discretion of attending obstetrician. Some of these women will need additional augmentation with oxytocin and it should be included in outcome measures.

    Ref: 1. Schulz KF, Grimes DA.Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002; 359: 515–19.


  • Is this paper outstanding in its discipline? (For example, would you like to see this work presented in a seminar at your hospital or university? Do you feel these results need to be incorporated in your next general lecture on the subject?) If yes, what makes it outstanding? If not, why not?

    Not applicable


  • Other Comments:

    None

  • Competing interests:
    .
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    I am a Professor of Obs & Gyn, teaching and practicing obstetrics for 28 years.

  • How to cite:  Aslam M .Induction of labour in women with nonscarred uterus using balloon catheter: Randomised controlled trial[Review of the article 'Induction of labour in women with nonscarred uterus using balloon catheter: Randomised controlled trial ' by Al Hazmi J].WebmedCentral 2016;7(3):WMCRW003277
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