A randomized clinical trial of Premaquick biomarkers versus transvaginal cervical length for pre-induction cervical assessment at term among pregnant women

Author:

Okafor Chigozie G1ORCID,Eleje George U12ORCID,Adinma Joseph I1,Ikechebelu Joseph I12ORCID,Umeh Eric O3,Okafor Chisolum O3,Ugwu Emmanuel O4,Ugboaja Joseph O1,Nwosu Betrand O1,Ezeama Chukwuemeka O1,Udigwe Gerald O12,Okoro Chukwuemeka C1ORCID,Egeonu Richard O1,Ezema Evaristus C5,Umeononihu Osita S1,Okpala Boniface C1ORCID,Okafor Chidinma C6,Ofojebe Chukwuemeka J1,Ilika Chito P1,Oguejiofor Charlotte B1,Ogabido Chukwudi A1,Umeokafor Chijioke C3,James John E1,Obiagwu Hillary I1,Okafor Lazarus U1,Obidike Afam B7,Okam Princeston C1,Okeke Kenneth N8,Inya Anselem O1,Njoku Tobechi K1,Eleje Lydia I9ORCID

Affiliation:

1. Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria

2. Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi Campus, Awka, Nigeria

3. Department of Radiology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria

4. Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Teaching Hospital, Enugu Campus, Enugu State, Nigeria

5. Essen Medical, Bronx, NY, USA

6. Paediatric Surgery unit, Great Ormond Street Hospital, London, UK

7. Department of Anaesthesia, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria

8. Department of Paediatrics, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria

9. Evaluation, Research and Statistics Unit, Department of Educational Foundations, Faculty of Education, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria

Abstract

Objectives: To compare Premaquick biomarkers (combined insulin-like growth-factor binding protein 1 and interleukin-6) and cervical length measurement via transvaginal ultrasound for pre-induction cervical evaluation at term among pregnant women. Methods: A randomized clinical trial of consenting pregnant women at the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. The women were randomized equally into Premaquick group ( n = 36) and transvaginal ultrasound group ( n = 36). The cervix was adjudged ‘ripe’ if the Premaquick test was positive or if the trans-vaginal measured cervical length was less than 28 mm. The primary outcome measures were the proportions of women who needed prostaglandin analogue for cervical ripening and the proportion that achieved vaginal delivery after induction of labour. The trial was registered in Pan African clinical trial registry (PACTR) registry with approval number PACTR202001579275333. Results: The baseline characteristics were similar between the two groups ( p > 0.05). There was no statistically significant difference between the two groups in terms of proportion of women that required prostaglandins for pre-induction cervical ripening (41.7 versus 47.2%, p = 0.427), vaginal delivery (77.8 versus 80.6%, p = 0.783), mean induction to delivery interval (22.9 ± 2.81 h versus 24.04 ± 3.20 h, p = 0.211), caesarean delivery (22.2 versus 19.4%, p = 0.783), proportion of neonate with birth asphyxia (8.30 versus 8.30%, p = 1.00) and proportion of neonate admitted into special care baby unit (16.7 versus 13.9%, p = 0.872). Subgroup analysis of participants with ‘ripe’ cervix at initial pre-induction assessment showed that the mean induction to active phase of labour interval and mean induction to delivery interval were significantly shorter in Premaquick than transvaginal ultrasound group. Conclusion: Pre-induction cervical assessment at term with either Premaquick biomarkers or transvaginal ultrasound for cervical length is effective, objective and safe with similar and comparable outcome. However, when compared with women with positive transvaginal ultrasound at initial assessment, women with positive Premaquick test at initial assessment showed a significantly shorter duration of onset of active phase of labour and delivery of baby following induction of labour.

Publisher

SAGE Publications

Subject

General Medicine

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