PPROMT Trial

Question 1

What was the hypothesis of the PPROMT trial?

Answer 1

Immediate delivery following PPROM close to term reduces risk of neonatal infection.

Question 2

What type of study was the PPROMT trial?

Answer 2

Multicentre, non-blinded RCT.

Question 3

What was the inclusion criteria for the PPROMT trial?

Answer 3

Inclusion criteria: 
- over 16 years old
- singleton pregnancy
PPROM between 34 to 36+6 weeks
- no signs of infection.

Question 4

What was the exclusion criteria for the PPROMT trial?

Answer 4

Exclusion criteria:

• established labour
• chorioamnionitis
• meconium staining
• other contraindication to continuing pregnancy.
• NOTE: GBS colonisation was NOT an exclusion criteria.

Question 5

Describe the study groups and method of the PPROMT trial:

Answer 5

• Immediate birth group. Delivery scheduled as close to randomisation as possible (ideally <24 hrs).
• Expectant management group. Birth occurred after spontaneous labour, at term or when another indication for delivery was identified.
• Women managed as per local guidelines. Antibiotics given as per local protocol.

Question 6

Describe the primary outcomes of the PPROMT trial:

Answer 6

Primary outcome:

- Neonatal sepsis

Question 7

Describe the secondary outcomes of the PPROMT trial:

Answer 7

Secondary outcomes:

• Composite neonatal morbidity and mortality indicators (sepsis, mechanical ventilation >=24 hours, stillbirth, neonatal death.
• RDS
• Any mechanical ventilation
• Duration of stay in SCBU/NICU
• APH or intrapartum haemorrhage
• Postpartum antibiotics
• Mode of delivery.

Question 8

What were the main findings and conclusions of the PPROMT trial?

Answer 8

Primary outcomes:
- Similar rates of neonatal sepsis 2% vs 3%

Secondary outcomes:
- Immediate delivery group had higher rates of RDS, mechanical ventilation and longer time in SCBU/NICU.

Conclusions: in the absence of infection or fetal compromise, PPROM women between 34 to 36+6 should be managed expectantly.

Question 9

How many women were recruited into the PPROMT Trial?

Answer 9

1839 women

Question 10

What was the setting of the PPROMT Trial?

Answer 10

65 centres, 11 countries
Multicentre RCT
2004-2013

Question 11

What was the effect of immediate management on RDS, in the PPROMT Trial?

Answer 11

Increased RDS
RR 1.6
Statistically significant

Question 12

What was the effect of immediate management on Mechanical ventilation, in the PPROMT Trial?

Answer 12

Increased

RR 1.4

Question 13

What was the effect of immediate management on time in NICU, in the PPROMT Trial?

Answer 13

Increased
4 days vs 2 days in the expectant management group
Statistically significant

Question 14

What were the maternal outcomes of the expectant management group in the PPROMT Trial?

Answer 14

Increased

• APH / IPH
• intrapartum fever
• postpartum antibiotics
• duration hospital stay

Decreased
- CS