Evidence map›Paper›PMID 34559884›Full record

SynthesisThe Cochrane database of systematic reviews2021

Instruments for assisted vaginal birth.

Ganga L Verma, Jessica J Spalding, Marc D Wilkinson, G Justus Hofmeyr, Valerie Vannevel, Fidelma O'Mahony

Registry-linked trialOpen access · bronzeAbstract readSystematic Review
In one paragraph

Synthesis in The Cochrane database of systematic reviews, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06918509 (ASSIST Ethiopia), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06918509 nacompletednot on this mapstarted 2025, after this paper: background citation

ASSIST Ethiopia: Feasibility Clinical Investigation of Assisted Vaginal Birth With the Odonassist™ Medical Device

TypeinterventionalSponsorDoctors with Africa - CUAMMRan2025 to 2026Enrolled20ConditionsInstrumental Delivery, Medical Device, Feasibility Study, Acceptability StudyArmsOdonAssistTM
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Hyaluronidase for reducing perineal trauma.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Vacuum 5-step technique versus OdonAssist: Which is easier to learn for professionals without experience in assisted vaginal births? A simulation study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Trial
  3. Trial
  4. Article
  5. Risk factors for subgaleal hemorrhage and adverse early neonatal outcomes: a single-center cohort study with exclusive use of forceps.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. The impact of metal cup size on neonatal and maternal morbidity in vacuum-assisted deliveries.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Article
  11. Maternal morbidity following a trial of labor after cesarean birth: A scoping review of operative vaginal birth compared with cesarean birth in the second stage of labor.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Subgaleal hemorrhage in neonates: a comprehensive review and summary recommendations.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Review
  17. Article
  18. Article
  19. Article
  20. Engaging women to set the research agenda for assisted vaginal birth.Health expectations : an international journal of public participation in health care and health policy · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Ganga L VermaDepartment of Obstetrics and Gynaecology, University Hospitals of Leicester, Leicester, UK.
Jessica J SpaldingDepartment of Obstetrics and Gynaecology, University Hospitals of North Midlands, Stoke-on-Trent, UK.
Marc D WilkinsonDepartment of Obstetrics and Gynaecology, University Hospitals of North Midlands, Stoke-on-Trent, UK.
G Justus HofmeyrWalter Sisulu University, University of Fort Hare, University of the Witwatersrand, Eastern Cape Department of Health, East London, South Africa & Department of Obstetrics and Gynaecology, University of Botswana, Gaborone, Botswana.
Valerie VannevelSAMRC Maternal and Infant Health Care Strategies Unit/University of Pretoria, Pretoria, South Africa.
Fidelma O'MahonyKeele University & Department of Obstetrics and Gynaecology, University Hospitals of North Midlands, Stoke-on-Trent, UK.
University Hospitals of North Midlands NHS Trust · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity of Fort Hare · ZAUniversity of Pretoria · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAssisted vaginal births are carried out to expedite birth for the benefit of mothers and babies but are sometimes associated with significant morbidity for both. Various instruments are available, broadly divided into forceps and vacuum cups, and choice may be influenced by clinical circumstances, operator preference, experience and availability. 

objectivesTo evaluate the different instruments in terms of success in achieving a vaginal birth, and the risk of morbidity for mother and baby. SEARCH

methodsWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (14 May 2021), and reference lists of retrieved studies. SELECTION CRITERIA: We selected randomised controlled trials of assisted vaginal birth using different instruments. The review did not include quasi-randomised trials, cluster-randomised trials or cross-over designs. The review included trials for which abstracts alone were available as long as there was sufficient information to assess eligibility.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We used the GRADE approach to assess the certainty of evidence.  The main outcomes assessed included failed delivery with allocated instrument, any maternal trauma, third- and fourth-degree tears, postpartum haemorrhage, any neonatal trauma, low Apgar and low umbilical artery pH.  MAIN

resultsWe included 31 studies involving a total of 5754 women.  Risk of bias criteria were largely assessed as 'unclear', due to a lack of detail in trial reports. Blinding would have been challenging for all trials due to their inability to conceal the type of instrument used from either the woman or the operator, which is reflected in the risk of bias assessment. Any type of forceps versus any type of vacuum cup (12 studies, 3129 women) Forceps may be less likely to fail in achieving vaginal birth: risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.88; 11 studies, 3080 women; low certainty. 'Any maternal trauma' may be slightly more likely with forceps: odds ratio (OR) 1.53, 95% CI 0.98 to 2.40; 5 studies, 1356 women; low certainty; and third- or fourth-degree tears may also be more likely with forceps: RR 1.83, 95% CI 1.32 to 2.55; 9 studies, 2493 women; low certainty. There is no evidence of a difference in the incidence of postpartum haemorrhage (PPH) between the two groups: RR 1.71, 95% CI 0.59 to 4.95; 2 studies, 523 women; low certainty, because the evidence is very imprecise due to a very wide CI.  More women in the forceps group reported requiring pain relief. There is probably no evidence of difference in rates of low Apgar: RR 0.83, 95% CI 0.46 to 1.51; 7 studies, 1644 women; moderate certainty; or low umbilical artery pH in the forceps group compared to any vacuum: RR 1.33, 95% CI 0.91 to 1.93; 2 studies, 789 women; low certainty; both of these outcomes are imprecise and have wide CIs that include both benefit and harm. There were also lower rates of fetal trauma with 'any forceps' (cephalhematoma, retinal haemorrhage and jaundice). The composite outcome of 'any neonatal trauma' was not reported. Low-cavity forceps versus any vacuum cup (2 studies, 218 women) We included two small studies with 218 participants in this comparison, but we judged most of the evidence as very low certainty, hence it was not feasible to make judgements on the difference in the rates of failed delivery, any maternal trauma or third- and fourth- degree tears. PPH and low umbilical artery pH were not reported. Soft vacuum cup versus any rigid cup (9 studies, 1148 women) Failed delivery may be more likely in the soft vacuum cup group: RR 1.62, 95% CI 1.21 to 2.17; 9 studies, 1148 women; low certainty. There may be no difference in the rates of 'any maternal trauma': OR 0.63, 95% CI 0.24 to 1.67; 2 studies, 348 women; low certainty, but the confidence interval is wide, indicating possible benefit or harm. There may be no difference in the rates of third- or fourth-degree tears: RR 0.93, 95% CI 0.35 to 2.44; 4 studies, 619 women; low certainty. There is probably no difference in the rates of PPH: RR 0.89, 95% CI 0.49 to 1.61; 5 studies, 737 women; moderate certainty between the soft and rigid cup groups.   There may be little or no difference in the incidence of low Apgar scores: RR 0.82, 95% CI 0.49 to 1.37; 9 studies, 1148; low certainty; or low umbilical artery pH: RR 0.80, 95% CI 0.47 to 1.36; 1 study, 100 women; low certainty. Handheld vacuum versus any vacuum cup (4 studies, 968 women) There may be no difference in the rates of failures with allocated instrument: RR 1.35, 95% CI 0.81 to 2.25; 4 studies, 962 women; low certainty, any maternal trauma: OR 1.16, 95% CI 0.71 to 1.88; 2 studies; 394 women; low certainty, PPH: RR 0.31, 95% CI 0.03 to 2.92; 1 study, 164 women; low certainty, low umbilical artery pH: RR 1.06, 95% CI 0.71 to 1.59; 1 study, 164 women; low certainty, or low Apgar scores: RR 1.25, 95% CI 0.34 to 4.61; 3 studies, 784 women; low certainty) between the two groups. There is probably no difference in the rates of third- or fourth-degree tears between the 'handheld vacuum' and 'any vacuum cup' groups: RR 1.15, 95% CI 0.62 to 2.12; 4 studies, 962 women; moderate certainty. AUTHORS'

conclusionsThis review provides low-certainty evidence that forceps may be more likely to achieve vaginal birth and have lower rates of fetal trauma, but at a greater risk of perineal trauma and higher pain relief requirements compared with vacuum cups. There was low-certainty evidence that rigid vacuum cups may be more likely to achieve a vaginal birth than soft cups but with more fetal trauma, whilst handheld vacuum cups had similar success rates compared to other cups. There was no evidence of a difference in the rates of third- or fourth-degree tears or postpartum haemorrhages between types of cups, but wide confidence intervals around the estimates indicate further research is needed in this area.

Indexed as

ParturitionPostpartum HemorrhageFemaleHumansInfantInfant, NewbornPregnancy

Identifiers

PMID34559884
PMCPMC8462579
OpenAlexW3199856332

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.