Progesterone For short cervix on screening

Question 1

What was the setting of this trial?

Answer 1

5 maternity hospitals in and around London

2003-2006

Question 2

What was the aim of the Progesterone for Shortened Cervix Trial?

Answer 2

To evaluate the effect of vaginal progesterone on the incidence of s-early PTB in asymptomatic women found at routine mid-trimester screening to have a short cervix

Question 3

What were the inclusion criteria for the progesterone for shortened cervix trial?

Answer 3

Singleton or twin

Undergoing routine USS at 20-25/40 for examination of fetal anatomy and growth

Question 4

What were exclusion criteria to the progesterone for shortened cervix trial?

Answer 4

Major fetal abnormalities
Painful regular uterine contractions
Ruptured membranes
Cervical cerclage

Question 5

How was gestational age determined in the Progesterone for Shortened Cervix Trial?

Answer 5

LMP
Confirmed from CRL measured at first-trimester scan
(Which was routine in all hospitals)

Question 6

How were women recruited to the Progesterone for Shortened Cervix Trial?

Answer 6

Women having routine ANC at time of fetal anatomy scan
Offered cervical length measurement by TV USS at median 22/40, as a predictor of sPTB.

If 15mm or less, recruited for randomisation

Question 7

What were the two intervention groups in the Progesterone for Shortened Cervix Trial?

Answer 7

• Progesterone PV 200mg nocte (micronised, Utrogestan), n =125
• Placebo nocte, n=125

24-33+6/40
No sexual intercourse

Question 8

What was the primary outcome of the progesterone for shortened cervix trial?

Answer 8

SPTB < 34/40

Question 9

What follow up did women receive during the Progesterone for Shortened Cervix Trial?

Answer 9

Visits for USS Growth and cervical length every 2/52 until 34/40
At each visit, asked about sleepiness, fatigue, headaches, vaginal irritation
Adherence checked by counting capsules

Question 10

What was the result of the primary outcome (sPTB < 34/40)

Answer 10

Statistically significant decrease in the progesterone group

Progesterone group 19.2%
Placebo 34.4%

RR 0.56

Question 11

What was the median cervical length in the study?

Answer 11

34mm

Question 12

What % of women in the study had a cervical length of 15mm or less?

Answer 12

1.3%

Question 13

What was the conclusion of the Progesterone for Shortened Cervix trial?

Answer 13

In women with a short cervix, treatment with progesterone reduces the rate of spontaneous early PTB.

These findings support a strategy of routine screening of pregnant women by USS measurement of cervical length