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Table 2 Primary outcome and external cephalic version (ECV) success after each attempt according to randomisation to talcum powder or aqueous gel

From: Talcum powder or aqueous gel to aid external cephalic version: a randomised controlled trial

 

Powder n = 48

Gel n = 47

P value

Relative risk (95% confidence interval)

 

Mean ± standard deviation, Median [interquartile range] or Number (%)

  

Primary outcome

    

ECV Related Maternal Pain VNRS*

6 [5–9]

8 [7–9]

P = 0.03

 

6.9 ± 2.2

7.9 ± 1.7

P = 0.02

 

ECV outcomes

    

First round of ECV (up to 2 attempts)

  

P = 0.31

RR 0.6 (95% CI 0.3–1.4)

Successful

21 (43.8)

26 (55.3)

  

Failed

27 (56.2)

21 (44.7)

  

First round of ECV (up to 2 attempts)

    

First ECV attempt

  

P = 0.99

RR 1.0 (95% CI 0.7–1.5)

Successful

20/48 (41.7)

19/47 (40.4)

  

Failed

28/48 (58.3)

28/47 (59.6)

  

Second ECV attempt (failed 1st attempt) n = 56

  

P = 0.07

 

Successful

1/28 (3.6)

7/28 (25.0)

  

Failed

23/28 (82.1)

17/28 (60.7)

  

Not attempted

4/28 (14.3)

4/28 (14.3)

  

Second round of ECV (up to 2 attempts)

    

Crossed-over (after failed 1st round) n = 48

To gel

To powder

P = 0.07

RR 3.9 (95% CI 1.0–15)

Yes

13/27 (48.1)

4/21 (19.0)

  

No

14/27 (51.9)

17/21 (81.0)

  

3rd ECV attempt (after cross-over) n = 17

Using gel

Using powder

P = 0.99

RR 0.8 (95% CI 0.1–6.0)

Successful

4/13 (30.8)

1/4 (25.0)

  

Failed

9/13 (69.2)

3/4 (75.0)

  

4th ECV attempt (after failed 3rd attempt) n = 12

Using gel

Using powder

P = 0.80

 

Successful

1/9 (11.1)

0/3 (0.0)

  

Failed

2/9 (22.2)

1/3 (33.3)

  

Not attempted

6/9 (66.7)

2 /3(66.7)

  

Cross-over round

  

P = 0.99

RR 1.9 (95% CI 0.2–23)

Successful

5/13 (38.5)

1/4 (25.0)

  

Failed

8/13 (61.5)

3/4 (75.0)

  
 

Powder

Gel

  

Final ECV outcome (cross-over included)

  

P = 0.84

RR 0.9 (95% CI 0.4–2.0)

Successful

26 (54.2)

27 (57.4)

  

Failed

22 (45.8)

20 (42.6)

  
  1. *Pain 10 point visual numerical rating scale (VNRS) with range from 1 to 10 (lower score, more pain) self-scored by participants immediately after up to 2 attempts completed (successful or otherwise) with allocated powder or gel.
  2. Defined as cephalic presentation confirmed by ultrasound following ECV with allocated powder or gel.
  3. Defined as cephalic presentation confirmed by ultrasound following ECV with allocated powder or gel and also after a crossover (after initial failure) to gel or powder if attempted analysed according to the original allocation to powder or gel.