Quality statement 2: Prophylactic vaginal progesterone and prophylactic cervical cerclage

Quality statement

Women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage.

Rationale

Preterm birth causes significant neonatal morbidity and mortality, as well as long-term disability. Therefore strategies for preventing preterm birth are important. Both prophylactic cervical cerclage and prophylactic vaginal progesterone[3] are effective in preventing or delaying preterm birth in women with a short cervix and a history of spontaneous preterm birth (up to 34+0 weeks of pregnancy) or mid-trimester loss (from 16+0 weeks of pregnancy onwards). Which treatment is best for each woman will depend on her individual preferences and circumstances, and women should be given information as part of shared decision making.

Quality measures

Structure

Evidence of local arrangements and written clinical protocols to ensure that women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage.

Data source: Local data collection.

Process

Proportion of women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy who are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage.

Numerator – the number in the denominator who are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage.

Denominator – the number of women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy.

Data source: Local data collection.

Outcome

Timing of labour and birth.

Data source: Local data collection.

What the quality statement means for different audiences

Service providers (secondary care services) ensure that women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage, with the choice of treatment depending on the woman's preferences and circumstances.

Healthcare professionals (such as obstetricians caring for women with high-risk pregnancies) offerwomenwho have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage, with the choice of treatment depending on the woman's preferences and circumstances.

Commissioners (clinical commissioning groups) commission services that ensure that women who have had a previous preterm birth or mid-trimester loss and have a cervical length of 25 mm or less measured between 16+0 and 24+0 weeks of pregnancy are offered a choice of either prophylactic vaginal progesterone[3] or prophylactic cervical cerclage, with the choice of treatment depending on the woman's preferences and circumstances.

Women at increased risk of preterm labour in whom an ultrasound scan has shown that they have a short cervix are offered a treatment to stop the cervix (neck of the womb) opening early and so delay labour and birth. This could be either progesterone (a natural female sex hormone) inserted into the vagina or a stitch in the cervix, with the choice of treatment depending on the woman's preferences and circumstances.

Source guidance

Preterm labour and birth (2015, updated 2019) NICE guideline NG25, recommendation 1.2.1

Definitions of terms used in this quality statement

Prophylactic vaginal progesterone

Progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth.

[NICE's full guideline on preterm labour and birth, glossary]

Prophylactic cervical cerclage

A treatment for cervical weakness (also termed cervical incompetence or insufficiency) to prevent preterm birth and miscarriage.

[Adapted from NICE's full guideline on preterm labour and birth]



[3] Although this use is common in UK clinical practice, at the time of publication (August 2019), vaginal progesterone did not have a UK marketing authorisation for this indication. The prescriber should see the summary of product characteristics for the manufacturer's advice on use in pregnancy. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.