How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    Appendix A: Methods and literature search strategy

    Methods and literature search strategy

    NICE has identified studies and reviews relevant to balloon disimpaction of the baby's head at emergency caesarean during the second stage of labour from the medical literature. Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    Search strategy design and peer review

    This search report is informed by the Preferred Reporting Items for Systematic reviews and Meta-Analyses literature search extension (PRISMA-S).

    A NICE information specialist ran the literature searches on 24/06/2024. See the search strategy history for the full search strategy for each database.

    The principal search strategy was developed in MEDLINE ALL (Ovid interface). It was adapted for use in each of the databases listed in table 4a, taking into account the database's size, search functionality and subject coverage. The MEDLINE ALL strategy was quality assured by a NICE senior information specialist. All translated search strategies were peer reviewed to ensure their accuracy. The quality assurance and peer review procedures were adapted from the Peer Review of Electronic Search Strategies (PRESS) 2015 evidence-based checklist.

    Review management

    The search results were managed in EPPI‑Reviewer version 5 (EPPI‑R5). Duplicates were removed in EPPI‑R5 using a 2‑step process. First, automated deduplication was done using a high-value algorithm. Second, manual deduplication was used to assess low-probability matches. All decisions about inclusion, exclusion and deduplication were recorded and stored.

    Limits and restrictions

    The CENTRAL database search removed trial registry records and conference material. The Embase search excluded conference material.

    English language limits were applied to the search when possible in the database. This is standard NICE practice for review topics.

    The search wasn't limited by date. Any records already identified by previous searches for this topic were found and removed through the de-duplication process in EPPI-R5.

    The limit to remove animal studies in the searches is standard NICE practice, which has been adapted from Dickersin K, Scherer R, Lefebvre C (1994) Systematic Reviews: Identifying relevant studies for systematic reviews. BMJ 309(6964): 1286.

    Main search

    Table 4a Main search results

    Database

    Date searched

    Database platform

    Database segment or version

    Number of results downloaded

    Cochrane Central Register of Controlled Trials (CENTRAL)

     24/06/2024

    Wiley

    Issue 5 of 12, May 2024

    57

    Cochrane Database of Systematic Reviews (CDSR)

     24/06/2024

    Wiley

    Issue 6 of 12, June 2024 

    1

    Embase

     24/06/2024

    Ovid

    1974 to 2024 June 21

    365

    INAHTA International HTA Database

     24/06/2024

     https://database.inahta.org/

    n/a

    5

    MEDLINE ALL

     24/06/2024

    Ovid

    1946 to 2024 June 21

    238

    Search strategy history

    MEDLINE ALL search strategy  

    1. (balloon* adj4 (dilat* or expand* or inflat* or device*)).tw. 20797 

    2. (cephalic adj4 elevat*).tw. 37 

    3. ((elevat* or (disimpact* or dis-impact*)) adj4 (foetal or fetal or fetus or foetus)).tw. 1249 

    4. ((foetal or fetal or fetus or foetus) adj4 (pillow* or balloon* or cushion*)).tw. 125 

    5. or/1-4 22175 

    6. cesarean section/ 54154 

    7. (caesarian or cesarian or caesarean or cesarean).tw. 76659 

    8. c-section.tw. 1872 

    9. (reverse breech adj4 (method* or technique* or extract* or deliver*)).tw. 30 

    10. or/6-9 90732 

    11. cephalopelvic disproportion/ or dystocia/ 4070 

    12. ((cephalopelvi* adj4 disproport*) or dystocia).tw. 5152 

    13. (cord adj4 prolapse).tw. 576 

    14. Fetal Distress/ 3546 

    15. Labor Presentation/ 4547 

    16. ((foetal or fetal or fetus or foetus) adj4 (distress* or non-reassuring or malpresentation*)).tw. 6387 

    17. or/11-16 19076 

    18. Labor Stage, Second/ 1649 

    19. ((engage* or impact* or fix*) adj4 (foetal or fetal or fetus or foetus) adj4 head*).tw. 175 

    20. ((obstruct* or second-stage or advanced) adj4 labo?r).tw. 4146 

    21. (full* adj4 dilat*).tw. 763 

    22. or/18-21 5508 

    23. 10 or 17 or 22 105876 

    24. 5 and 23 270 

    25. Fetal Pillow.tw. 18 

    26. Fetal Disimpacting System.tw. 0 

    27. 25 or 26 18 

    28. 24 or 27 271 

    29. animals/ not humans/ 5199241 

    30. 28 not 29 255 

    31. limit 30 to English language 238 

    Embase search strategy  

    1. balloon dilatation/ 24552 

    2. (balloon* adj4 (dilat* or expand* or inflat* or device*)).tw. 36065 

    3. (cephalic adj4 elevat*).tw. 39 

    4. Fetal head elevator/ 35 

    5. ((elevat* or (disimpact* or dis-impact*)) adj4 (foetal or fetal or fetus or foetus)).tw. 1797 

    6. ((foetal or fetal or fetus or foetus) adj4 (pillow* or balloon* or cushion*)).tw. 224 

    7. or/1-6 49535 

    8. cesarean section/ 131355 

    9. (caesarian or cesarian or caesarean or cesarean).tw. 112027 

    10. c-section.tw. 5008 

    11. (reverse breech adj4 (method* or technique* or extract* or deliver*)).tw. 48 

    12. or/8-11 154807 

    13. cephalopelvic disproportion/ or dystocia/ 6482 

    14. ((cephalopelvi* adj4 disproport*) or dystocia).tw. 6828 

    15. umbilical cord prolapse/ 517 

    16. (cord adj4 prolapse).tw. 730 

    17. Fetus Distress/ 10356 

    18. malpresentation/ 1592 

    19. ((foetal or fetal or fetus or foetus) adj4 (distress* or non-reassuring or malpresentation*)).tw. 9351 

    20. or/13-19 25008 

    21. ((engage* or impact* or fix*) adj4 (foetal or fetal or fetus or foetus) adj4 head*).tw. 258 

    22. Obstructed labor/ or Labor stage 2/ 3307 

    23. ((obstruct* or second-stage or advanced) adj4 labo?r).tw. 5579 

    24. (full* adj4 dilat*).tw. 1294 

    25. or/21-24 7933 

    26. 12 or 20 or 25 171382 

    27. 7 and 26 694 

    28. Fetal Pillow.tw. 52 

    29. Fetal Disimpacting System.tw. 2 

    30. 28 or 29 54 

    31. 27 or 30 695 

    32. Nonhuman/ not Human/ 5467922 

    33. 31 not 32 678 

    34. (conference abstract or conference paper or conference proceeding or "conference review").pt. 5976910 

    35. 33 not 34 410 

    36. limit 35 to English language 364 

     

    Cochrane Library (CDSR and CENTRAL) search strategy

    1. (balloon* near/4 (dilat* or expand* or inflat* or device*)):ti,ab,kw 2613 

    2. (cephalic near/4 elevat*):ti,ab,kw 3 

    3. ((elevat* or (disimpact* or dis-impact*)) near/4 (foetal or fetal or fetus or foetus)):ti,ab,kw 38 

    4. ((foetal or fetal or fetus or foetus) near/4 (pillow* or balloon* or cushion*)):ti,ab,kw 52 

    5. #1 or #2 or #3 or #4 2693 

    6. MeSH descriptor: [Cesarean Section] this term only 4504 

    7. (caesarian or cesarian or caesarean or cesarean):ti,ab,kw 17871 

    8. (c-section):ti,ab,kw 433 

    9. (reverse breech near/4 (method* or technique* or extract* or deliver*)):ti,ab,kw 11 

    10. #6 or #7 or #8 or #9 18014 

    11. MeSH descriptor: [Cephalopelvic Disproportion] this term only 1 

    12. MeSH descriptor: [Dystocia] this term only 148 

    13. (cephalopelvi* near/4 disproport* or dystocia):ti,ab,kw 673 

    14. (cord near/4 prolapse):ti,ab,kw 80 

    15. MeSH descriptor: [Fetal Distress] this term only 199 

    16. MeSH descriptor: [Labor Presentation] this term only 105 

    17. ((foetal or fetal or fetus or foetus) near/4 (distress* or non-reassuring or malpresentation*)):ti,ab,kw 1132 

    18. #11 or #12 or #13 or #14 or #15 or #16 or #17 1864 

    19. MeSH descriptor: [Labor Stage, Second] explode all trees 255 

    20. ((engage* or impact* or fix*) near/4 (foetal or fetal or fetus or foetus) near/4 head):ti,ab,kw 35 

    21. ((obstruct* or second-stage or advanced) near/4  labo?r):ti,ab,kw 1191 

    22. (full* near/4 dilat*):ti,ab,kw 272 

    23. #19 or #20 or #21 or #22 1434 

    24. #10 or #18 or #23 19652 

    25. #5 and #24 123 

    26. (Fetal Pillow):ti,ab,kw 22 

    27. (Fetal Disimpacting System):ti,ab,kw 0 

    28. #26 or #27 22 

    29. #25 or #28  136 

    30. "conference":pt or (clinicaltrials or trialsearch):so    750874 

    31. #29 not #30      58 

    INAHTA HTA Database search strategy

    1. (balloon* AND (dilat* or expand* or inflat* or device*) 

    2. (cephalic elevat*) 

    3. (foetal or fetal or fetus or foetus) AND (elevat* or disimpact* or dis-impact) 

    4. (foetal or fetal or fetus or foetus) AND (balloon or pillow or cushion) 

    5. #1 OR #2 OR #3 OR #4 

    6. "Cesarean Section"[mh] 

    7. (caesarian or cesarian or caesarean or cesarean) 

    8. (c-section) 

    9. (reverse breech AND (method* or technique* or extract* or deliver*)) 

    10. "Cephalopelvic Disproportion"[mh] 

    11. "Dystocia"[mh]            

    12. ((cephalopelvi* AND disproport*) or dystocia) 

    13. (cord AND prolapse) 

    14. "Fetal Distress"[mh] 

    15. "Labor Presentation"[mh] 

    16. ((foetal or fetal or fetus or foetus) AND (distress* or non-reassuring or malpresentation*)) 

    17. "Labor Stage, Second"[mh] 

    18. ((engage* or impact* or fix*) AND (foetal or fetal or fetus or foetus) adj4 head*) 

    19. ((obstruct* or second-stage or advanced) AND (labor or labour) 

    20. (full* AND dilat*) 

    21. #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 

    22. ("fetal pillow" or "fetal disimpacting system") 

    23. #5 AND #21 

    24. #22 OR #23 

    Inclusion criteria

    The following inclusion criteria were applied to the abstracts identified by the literature search.

    Publication type: clinical studies were included with emphasis on identifying good quality studies. Abstracts were excluded if they did not report clinical outcomes. Reviews, editorials, and laboratory or animal studies, were also excluded and so were conference abstracts, because of the difficulty of appraising study methodology, unless they reported specific adverse events not available in the published literature.

    People having an emergency caesarean during the second stage of labour, with an impacted fetal head.

    Intervention or test: balloon disimpaction.

    Outcome: articles were retrieved if the abstract contained information relevant to the safety, efficacy, or both.

    If selection criteria could not be determined from the abstracts the full paper was retrieved.

    Potentially relevant studies not included in the main evidence summary are listed in Appendix B: Other relevant studies.

    Find out more about how NICE selects the evidence for the committee.