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Progestogen (Preterm Birth Prevention) Pregnancy: Indicated in pregnancy for preterm birth prevention in selected women

Hydroxyprogesterone Caproate / Progesterone (Preterm Birth Prevention)

Brand names: Makena (hydroxyprogesterone caproate — IM), Utrogestan 200 mg (vaginal)

Adult dose

Dose: Hydroxyprogesterone caproate: 250 mg IM weekly from 16–20 weeks to 36 weeks. Vaginal progesterone (preferred in UK): 200 mg vaginally OD from 16–24 weeks in women with short cervix (<25 mm on TVU) to 36 weeks
Route: IM (hydroxyprogesterone caproate) or vaginal (progesterone)
Frequency: Weekly (IM) or once daily (vaginal)
Max: 250 mg/week (IM); 200 mg/day (vaginal)
NICE NG25: progesterone 200 mg vaginal OD recommended for women with singleton pregnancy, previous spontaneous preterm birth, and cervical length <25 mm on TVU at 16–24 weeks. PROLONG trial challenged hydroxyprogesterone caproate efficacy in non-selected populations — vaginal route preferred in UK.

Paediatric dose

Route: N/A
Frequency: N/A
Max: N/A
Not applicable in paediatric patients

Dose adjustments

Renal

No dose adjustment required

Hepatic

Avoid in severe hepatic impairment

Clinical pearls

  • NICE NG25: vaginal progesterone 200 mg OD in singleton pregnancies with previous PTB and cervical length <25 mm — reduces preterm birth risk
  • PROLONG trial (2019): failed to show benefit of IM 17-OHPC in broader population — vaginal progesterone now preferred over IM in UK
  • Cervical cerclage: consider in conjunction with progesterone in women with cervical length <25 mm and previous PTB or cervical insufficiency
  • Not indicated for multiple pregnancies for PTB prevention — OPPTIMUM and other trials showed no benefit
  • TVU cervical length screening at 16–24 weeks identifies women who benefit most

Contraindications

  • Multiple pregnancy (no evidence of benefit for PTB prevention)
  • Known/suspected hormone-sensitive tumour
  • Severe hepatic impairment
  • Thromboembolic disease

Side effects

  • Injection site pain/reactions (IM route)
  • Local vaginal irritation
  • Breast tenderness
  • Somnolence (vaginal route — absorbs systemically)

Interactions

  • Enzyme inducers (rifampicin, carbamazepine) — reduced progesterone levels

Monitoring

  • TVU cervical length (monitoring response)
  • Uterine contraction frequency
  • Signs of preterm labour

Reference: BNFc; NICE NG25 Preterm Labour and Birth; PROLONG Trial (Blackwell SC, 2019); BNF; RCOG. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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