Immediate start of combined hormonal contraceptives for contraception
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
This review will examine randomized controlled trials of immediate‐start combined hormonal contraceptives for contraception.
Background
Although 75 million women use oral contraceptive pills worldwide (UNDP 2003), the optimal time to start the pill remains unknown. Traditionally, women have been instructed to start oral contraceptives in relation to their menstrual cycle: either on day one or within the first days of their menses (Kubba 1993) or on the Sunday after their menses begins (Williams‐Deane 1992). Most health care providers and pharmaceutical companies suggest multiple options for starting oral contraceptives, all of which are timed in relation to menses (Williams‐Deane 1992). These multiple options can create confusion regarding when to start the pill. Furthermore, menstruation requirements for initiation of contraception impede access to contraception for women with real or perceived irregular menses and for women in developing countries. From 41% to 92% of family planning clients in developing countries are denied contraceptive services if they are not menstruating at the time of their visit (Stanback 1997; Stanback 1999).
The recommendation for women to wait until the next menses to begin oral contraceptives is based on an attempt to avoid starting contraception during an undetected pregnancy. However, with this approach, studies have shown that as many as 25% of women do not start taking the pill (Polaneczky 1994) and of those who do, less than 50% take it daily (Oakley 1991). During this delay in contraceptive initiation, unintended pregnancies occur, women's intentions for contraceptive use change, women may forget instructions, and fears of side effects increase (Westhoff 2002). This medically imposed delay in starting contraception results in many unintended pregnancies worldwide, along with their related morbidity and mortality, and may increase the cost of family planning as a result of increasing the number of repeat/return clinic visits.
An alternative is to start combined oral contraceptives immediately, with back‐up contraception for the first seven days (Lara‐Torre 2004). This novel method has been termed 'Quick Start' and may improve initiation and continuation rates of oral contraceptives, among both adolescents and adults, when compared to conventional start methods (Westhoff 2002; Lara‐Torre 2002). This method of immediate initiation of birth control was originally introduced with combined oral contraceptives and has now expanded to the combined hormonal vaginal ring (Westhoff 2005) and the transdermal contraceptive patch (Murthy 2005).
How immediate initiation of combined hormonal contraception compares to conventional start with respect to acceptability, continuation, and efficacy remains unclear. If accepted globally, the immediate start approach of combined hormonal contraception may improve women's access to, and initiation of, contraception. This review will examine randomized controlled trials comparing immediate versus conventional initiation of combined hormonal contraceptives for contraception. We will also examine trials comparing immediate initiation of different routes (oral, vaginal, and transdermal) of hormonal contraceptives.
Objectives
This review will examine randomized controlled trials of immediate‐start combined hormonal contraceptives for contraception.
Methods
Criteria for considering studies for this review
Types of studies
We will include all randomized controlled trials in any language that compare immediate start of hormonal contraceptives to conventional start of hormonal contraceptives. We will also include all randomized trials in any language which compare immediate start of different types of hormonal contraceptives with each other.
Types of participants
All women included in the eligible trials will be incorporated in this review.
Types of interventions
We will include any contraception initiation method: immediate start and start in relation to timing of menses. We will include any type of hormonal contraceptives: oral, intramuscular, transdermal, or transvaginal.
Types of outcome measures
Contraceptive efficacy, continuation rates, bleeding patterns, acceptability, and other side effects.
Search methods for identification of studies
We will search PubMed using the following strategy: (contraceptive agents, female OR (steroid* AND contracept*) OR orthoevra OR "ortho evra" OR "norelgestromin" OR (contraceptive devices, female and ring) OR NuvaRing OR cyclofem OR lunelle OR mesigyna OR cycloprovera OR (medroxyprogesterone 17‐acetate AND (contracept* OR inject* OR depo OR depot)) OR depot medroxyprogesterone OR depo medroxyprogesterone OR depotmedroxyprogesterone OR depomedroxyprogesterone OR dmpa OR "net en" OR norethisterone enantate OR norplant OR uniplant OR jadelle OR implanon OR ((levonorgestrel OR etonogestrel) AND implant) OR (levonorgestrel AND intrauterine devices) OR mirena OR ((progestational hormones OR progestin) AND contracept* AND (oral OR pill* OR tablet*))) AND (((time factors OR immediate OR timing) AND (start* OR begin* OR initiat*)) OR "quick start"OR starting day OR drug administration schedule)
We will search CENTRAL using the following strategy: contracept* and (initiat* or start* or begin* or quick start or drug adminstration schedule)
We will search POPLINE using the following strategy:(Contraceptive Agents Female/depo provera/dmpa/medroxyprogesterone/(steroid* & contracept*) /orthoevra/ortho evra /norelgestromin/(contraceptive devices, female and ring)/ NuvaRing /cyclofem /lunelle/ mesigyna/ cycloprovera/ (medroxyprogesterone 17‐acetate & (contracept* /inject*/depo/depot))/ depot medroxyprogesterone/ depo medroxyprogesterone/ depot medroxyprogesterone/depo medroxyprogesterone/dmpa/ net en/ norethisterone‐enantate/norplant/uniplant/jadelle/implanon/((levonorgestrel/ etonogestrel) & implant)/(levonorgestrel & intrauterine devices)/mirena /((progestational hormones/progestin) & contracept* & (oral/pill*/tablet*))) & (start & (quick/immediate/time/timing))/"quick start"
We will search LILACS using the following strategy: contraceptive agents, female or agentes anticonceptivos femeninos or anticoncepcionais femeninos or contraceptives, oral or anticonceptivos orales or anticoncepcionais orais [Words] and start or initiator or inciador or begin or beginning or comienzo or incio or initiation or quick start or starting day or drug administation schedule [Words]
We will search EMBASE using the following strategy: CONTRACEPTIVE AGENT? OR STEROID?(W)CONTRACEPT?
AND DRUG ADMINISTRATION AND (QUICK(W)START OR START? OR INITIAT?OR BEGIN?).
Data collection and analysis
We will assess all titles and abstracts found for inclusion. We will evaluate the methodological quality of the trials for potential bias by qualitatively assessing study design, randomization method, allocation concealment, blinding, early discontinuation rates, and loss to follow‐up rates. Two reviewers will independently abstract data from the studies identified to improve accuracy. We will enter data into RevMan 4.2, and a second reviewer will confirm correct data entry. Peto odds ratios with 95% confidence intervals will be used for dichotomous outcomes, such as pregnancy and certain bleeding outcomes. For continuous outcomes, such as number of bleeding days, we will examine weighted mean differences. We will contact authors of published trials when supplementary information is needed and will ask authors to help identify other published or unpublished trials that we may have missed.
