Bibliographic information

GuidelineWHO recommendation on tocolytic therapy for improving preterm birth outcomes.
Year of Publication2022
Issuing InstitutionWorld Health Organization

Recommendation

Maintained
Originally developed

Nifedipine is recommended for acute and maintenance tocolytic therapy for women with a high likelihood of preterm birth for the purpose of improving newborn outcomes, when the following conditions are met: Spontaneous preterm labour is suspected or diagnosed; Gestational age is accurately assessed to be between 24 weeks 0 days and 33 weeks 6 days; There is no evidence that tocolysis is contraindicated (such as vaginal bleeding, placental abruption or intrauterine infection); It permits a single course of antenatal corticosteroids to be administered and/or enables transfer of the mother to a facility where, upon birth, the preterm infant can receive adequate care (including resuscitation, kangaroo mother care, thermal care, feeding support, infection treatment and respiratory support including continuous positive airway pressure as needed); Adequate birth care is available (including capacity to recognize and safely manage preterm labour and birth)

Context specific recommendation

Only in specific contexts

Notes and Remarks

REMARKS Q The GDG considered nifedipine to be the preferred option as the balance of benefits and harms, cost, acceptability and feasibility was superior to other tocolytic agents. The GDG acknowledged that oxytocin receptor antagonists and nitric oxide donors can prolong pregnancy, but are not available in many countries and can be more costly. Q Based on the available trials, the commonlyused regimen for nifedipine (immediaterelease) is an initial oral dose of 20 mg followed by 10 mg every 6 hours for 3–7 days or until transfer is completed, whichever comes first. Q The GDG noted that COX inhibitors do have a tocolytic effect (delaying birth up to 48 hours) and may be considered in the management of preterm labour prior to 28 weeks . They are contraindicated, however, in the third trimester due to an association with increased risk of premature closure of the ductus arteriosus and the potential for renal dysfunction leading to oligohydramnios. Q Available trials suggest that while magnesium sulfate has a tocolytic effect (delaying birth by 48 hours), other tocolytic agents have greater benefits and fewer side-effects. Q Although betamimetics appear effective in delaying birth, their use is associated with a risk of serious maternal adverse effects, which may sometimes be life-threatening. Q Combination therapy does not have more benefits than monotherapy options, and therefore the GDG recommends monotherapy only. Q The GDG noted that 40% of tocolytic trials used an acute plus maintenance regimen, though the benefits of a maintenance regimen (beyond acute tocolysis) could not be determined. The GDG therefore agreed that acute plus maintenance tocolysis with nifedipine is optimal in the management of preterm labour, though further research is required. Q The GDG acknowledged that trials largely enrolled women with intact membranes – only 9% of women in these trials had ruptured membranes. There was insufficient evidence to conclude on the benefits or possible harms of tocolysis in this subgroup. The GDG therefore indicated that tocolytics can be considered in women with ruptured membranes, if there are no contraindications such as intrauterine infection. This was considered a research priority. Q The available trials included women with singleton and multiple pregnancies. While it was not possible to draw conclusions on the effects of tocolytics in women with multiple pregnancies, they are likely to benefit from tocolysis. Q Women and families should receive adequate information about the benefits and risks of tocolysis. There is a lack of information on the long-term outcomes following tocolysis, which should be discussed with the woman and her family in order for an informed decision regarding the woman’s care to be taken. Q There are separate WHO recommendations relating to use of antenatal corticosteroids for women with a high likelihood of preterm birth prior to 34 weeks’ gestation (33).

Also Featured In

This recommendation also appears in the following guidelines:

Guideline

WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee, second edition. Geneva: World Health Organization; 2025

Year2023
InstitutionWorld Health Organization