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Progestogen (Preterm Birth Prevention)

Hydroxyprogesterone Caproate / Progesterone (Preterm Birth Prevention)

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

A progestogen used to reduce the risk of recurrent spontaneous preterm birth in selected women with a prior preterm delivery, and historically to support pregnancy maintenance.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

As a synthetic progestogen it acts on progesterone receptors to promote uterine quiescence and suppress myometrial contractility.

Prescribing in practice

  • Restrict use to appropriately selected women and only after counselling, as evidence of benefit for recurrent preterm birth prevention is contested and the licensing position has been reassessed in some jurisdictions; vaginal progesterone is the preferred option in many UK pathways.
  • Confirm singleton pregnancy and prior history criteria before initiating, as benefit has not been demonstrated in multiple pregnancy.
  • Avoid in active or past hormone-sensitive malignancy, undiagnosed vaginal bleeding, and significant hepatic impairment.

Monitoring

Monitor for injection-site reactions, signs of venous thromboembolism, and ongoing obstetric review of cervical length and gestation.

Counselling the patient

  • Report calf pain, swelling, breathlessness or chest pain promptly as these may indicate a clot.
  • Attend all planned antenatal scans and appointments so treatment can be reviewed.
  • Discuss the uncertainty around benefit so you can make an informed choice.

Evidence & guidelines

UK practice (NICE NG25) generally favours vaginal progesterone for preterm birth prevention, and the efficacy of hydroxyprogesterone caproate has been questioned by later trial data such as PROLONG.

Reference: NICE NG25 Preterm Labour and Birth; PROLONG Trial (Blackwell SC, 2019); RCOG; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.